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 K922441
Device Name SURESEAL BANDAGE
Applicant
Gainor Medical Europe, Ltd.
310 Holden Shore
Sutie 240
Long Beach,  CA  90802
Applicant Contact GAINOR
Correspondent
Gainor Medical Europe, Ltd.
310 Holden Shore
Sutie 240
Long Beach,  CA  90802
Correspondent Contact GAINOR
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/22/1992
Decision Date 08/10/1993
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
-
-