Medical Device Manufacturer · US , Ringwood , NJ

Primary Care Solutions, Inc.

4 submissions · 4 cleared · Since 2001

Total

Cleared

Denied

Primary Care Solutions, Inc. — FDA 510(k) Submissions

Primary Care Solutions, Inc. has submitted 4 FDA 510(k) premarket notifications since 2001, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter And Tip, Suction, Catheter, Retention Type, Balloon, Dressing, Wound, Drug . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION

K082330 · FRO Dressing, Wound, Drug · General & Plastic Surgery

Oct 2008 56d

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

K030813 · EZL Catheter, Retention Type,... · Gastroenterology & Urology

May 2003 77d

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

K000265 · JOL Catheter And Tip, Suction · General Hospital

Jul 2001 531d

PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION