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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K994313
Device Name MODIFICATION TO BONE ANCHOR AND KIT (BAK)
Applicant
Axya Medical, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact HOWARD L SCHRAYER
Correspondent
Axya Medical, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact HOWARD L SCHRAYER
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
MBI  
Date Received12/22/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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