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 K915695
Device Name PROCEL BURN COVER
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Applicant Contact LARRY KOVACH
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Correspondent Contact LARRY KOVACH
Classification Product Code
MGP  
Date Received12/23/1991
Decision Date 05/29/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-