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 And Burn, Occlusive
510(k) Number K973036
Device Name 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
Applicant
3M Healthcare
P.O. Box 33275
3m Center, 275-3e-08
St. Paul,  MN  55144 -1000
Applicant Contact KAREN C HOLMEN
Correspondent
3M Healthcare
P.O. Box 33275
3m Center, 275-3e-08
St. Paul,  MN  55144 -1000
Correspondent Contact KAREN C HOLMEN
Classification Product Code
MGP  
Date Received08/14/1997
Decision Date 11/12/1997
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
-
-