Paragon Packaging Incorporated

FDA Device Registration & Listing · Old Bridge, NJ, US · Registration 1000136042

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000136042
FEI Number
1000136042
Entity Name
Paragon Packaging Incorporated
City/State/Country
Old Bridge, NJ, US
Establishment Address
200 Fairway Lane, Old Bridge, NJ 08857, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Paragon Packaging Incorporated (Owner Number: 10044101)
Owner / Operator Contact Address
200 Fairway Lane, Old Bridge, NJ 08857, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182438
PMA Number
N/A

All Registered Proprietary Names

Condom Condom Condom Condom Condom

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LTZ Condom With Nonoxynol-9 Obstetrics/Gynecology Class 2 884.5310 2013-04-30
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2013-04-30
LTZ Condom With Nonoxynol-9 Obstetrics/Gynecology Class 2 884.5310 2013-04-30
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2013-04-30
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2021-10-11
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2021-10-11
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2021-10-11
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2013-04-30
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2017-11-17
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2013-04-30
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2017-11-17
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2021-10-11

Official Correspondent

Denise Burdick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Paragon Packaging Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000136042. Last updated year: 2026. Please use registration number 1000136042 when referencing this establishment in official correspondence.
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