Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012118920

FEI Number

3012118920

Entity Name

Summit Packaging Solutions LLC

City/State/Country

Shippensburg, PA, US

Establishment Address

9300 Olde Scotland Rd, Shippensburg, PA 17257, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Summit Packaging Solutions LLC (Owner Number: 10051178)

Owner / Operator Contact Address

2481 Wright Blvd, Hebron, KY 41048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061486

PMA Number

N/A

All Registered Proprietary Names

Unscented Menstrual Tampon Powered Toothbrush Unscented Menstrual Pad Incontience Protective Garment Oral Hygiene Rubber Tip Powered Toothbrush Deodorized Scented Menstrual Pad Dental Hygiene Kit Powered Toothbrush Massaging Pick Unscented Menstrual Tampon Deodorized Scented Menstrual Tampon Unscented Menstrual Tampon Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture Unscented Menstrual Tampon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2016-12-28
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-12-28
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2016-12-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-12-28
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2016-12-28
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-12-28
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2016-12-28
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2016-12-28
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-12-28
JET	Pick, Massaging	Dental	Class 1	872.6650	2016-12-28
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2016-12-28
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2016-12-28
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2016-12-28
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2016-12-28
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	Dental	Class 1	872.3490	2016-12-28
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2016-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summit Packaging Solutions LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012117640	Summit Packaging Solutions LLC	Jackson, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

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3011964664	PROCTER & GAMBLE DISTRIBUTING LLC, THE	Union, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012118920. Last updated year: 2026. Please use registration number 3012118920 when referencing this establishment in official correspondence.