Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter And Tip, Suction
510(k) Number K000266
Device Name PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
Applicant
Primary Care Solutions, Inc.
339 Stonetown Rd.
Ringwood,  NJ  07456
Applicant Contact NORMAN RUEDT
Correspondent
Primary Care Solutions, Inc.
339 Stonetown Rd.
Ringwood,  NJ  07456
Correspondent Contact NORMAN RUEDT
Regulation Number880.6740
Classification Product Code
JOL  
Date Received01/28/2000
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-