RONDO-PAK

FDA Device Registration & Listing · Camden, NJ, US · Registration 3013770781

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
3013770781
FEI Number
3013770781
Entity Name
RONDO-PAK
City/State/Country
Camden, NJ, US
Establishment Address
1200 Ferry Ave, Camden, NJ 08104, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Rondo-Pak (Owner Number: 10087400)
Owner / Operator Contact Address
1200 Ferry Ave, Camden, NJ 08104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K940046
PMA Number
N/A

All Registered Proprietary Names

LifeStyles (Flavors & Colors) Lifestyles Closer Connection SKYN Excitation SKYN Selection (Excitation) SKYN All Night Long LifeStyles Non-Lubricated

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2025-11-17
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2023-02-22
MOL Condom, Synthetic Obstetrics/Gynecology Class 2 884.5300 2025-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2025-11-17
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rondo-Pak
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
K050212 Qualis, Inc. PERSONAL WARMING JELLY 2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013770781. Last updated year: 2026. Please use registration number 3013770781 when referencing this establishment in official correspondence.
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