Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030049002

FEI Number

3030049002

Entity Name

ROWPAR PHARMACEUTICALS INC.

City/State/Country

Bridgewater, NJ, US

Establishment Address

440 Us Highway 22 Ste 210, Bridgewater, NJ 08807, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Rowpar Pharmaceuticals Inc. (Owner Number: 10094489)

Owner / Operator Contact Address

440 US Hwy 22, Ste 210, Bridgewater, NJ 08807, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250390

PMA Number

N/A

All Registered Proprietary Names

CloSYS Dry Mouth Sensitive Mouth Rinse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFD	Saliva, Artificial	Unknown	Class U	N/A	2025-12-03

Official Correspondent

Michael Tune

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rowpar Pharmaceuticals Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030049002. Last updated year: 2026. Please use registration number 3030049002 when referencing this establishment in official correspondence.