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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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