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 Punch, Surgical
510(k) Number K933516
Device Name ACU-E PUNCH
Applicant
Acuderm, Inc.
5370 NW 35th Terrace
Ft. Lauderdale,  FL  33309
Applicant Contact CHARLES R YEH
Correspondent
Acuderm, Inc.
5370 NW 35th Terrace
Ft. Lauderdale,  FL  33309
Correspondent Contact CHARLES R YEH
Regulation Number878.4800
Classification Product Code
LRY  
Subsequent Product Codes
FZT   FZY  
Date Received07/20/1993
Decision Date 03/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-