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 suture, absorbable, synthetic, polyglycolic acid
510(k) Number K022664
Device Name PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
Applicant
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
1591 S. MOORLAND RD.
SUITE 104
NEW BERLIN,  WI  53151
Applicant Contact CHARLES F ANDREWS
Correspondent
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
1591 S. MOORLAND RD.
SUITE 104
NEW BERLIN,  WI  53151
Correspondent Contact CHARLES F ANDREWS
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/09/2002
Decision Date 09/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-