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 Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K002639
Device Name BIOKNOTLESS ANCHOR
Applicant
MITEK PRODUCTS
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Applicant Contact MARY P LEGRAW
Correspondent
MITEK PRODUCTS
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Correspondent Contact MARY P LEGRAW
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
MAI  
Date Received08/24/2000
Decision Date 05/11/2001
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
Recalls CDRH Recalls
-
-