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 K930457
Device Name MEDIMAC BANDAGE
Applicant
Enquay Pharmaceutical
2840 NW 2nd Ave.
Suite 213
Boca Raton,  FL  33431
Applicant Contact BERNARD KOROL
Correspondent
Enquay Pharmaceutical
2840 NW 2nd Ave.
Suite 213
Boca Raton,  FL  33431
Correspondent Contact BERNARD KOROL
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/28/1993
Decision Date 01/25/1994
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
-
-