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 Mesh, Surgical, Polymeric
510(k) Number K942911
Device Name GLYCAR TISSUE REPAIR PATCH
Applicant
Glycar, Inc.
4537 Belclaire Ave.
Dallas,  TX  75205
Applicant Contact DIRK A FRATER, M.D.
Correspondent
Glycar, Inc.
4537 Belclaire Ave.
Dallas,  TX  75205
Correspondent Contact DIRK A FRATER, M.D.
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/21/1994
Decision Date 12/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-