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 Staple, Implantable
510(k) Number K970817
Device Name MICROMARK CLIP
Applicant
Biopsys Medical, Inc.
#3 Morgan
Irvine,  CA  92618
Applicant Contact MARK A COLE
Correspondent
Biopsys Medical, Inc.
#3 Morgan
Irvine,  CA  92618
Correspondent Contact MARK A COLE
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/06/1997
Decision Date 09/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-