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 K072863
Device Name ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
Applicant
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact ALLAN P SCHWARTZ
Correspondent
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact ALLAN P SCHWARTZ
Regulation Number878.4493
Classification Product Code
GAM  
Date Received10/05/2007
Decision Date 05/23/2008
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
-
-