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 Wound Dressing With Animal-Derived Material(S)
510(k) Number K901369
Device Name GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
Applicant
Sterling Drug, Inc.
90 Park Ave.
New York,  NY  10016
Applicant Contact LINDA L NARDONE,PHD
Correspondent
Sterling Drug, Inc.
90 Park Ave.
New York,  NY  10016
Correspondent Contact LINDA L NARDONE,PHD
Classification Product Code
KGN  
Date Received03/23/1990
Decision Date 06/05/1990
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-