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 Dressing, Wound, Drug
510(k) Number K973717
Device Name COMBIDERM ACD
Applicant
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact ADRIENNE MCNALLY
Correspondent
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact ADRIENNE MCNALLY
Classification Product Code
FRO  
Date Received09/29/1997
Decision Date 12/17/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-