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 Tape And Bandage, Adhesive
510(k) Number K852408
Device Name EXTRA LARGE ADHESIVE STRIPS
Applicant
AMERICAN WHITE CROSS, INC.
56 WESTCOTT RD.
STAMFORD,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
AMERICAN WHITE CROSS, INC.
56 WESTCOTT RD.
STAMFORD,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/06/1985
Decision Date 07/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-