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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K021382
Device Name SYNTHES (USA) AUTOMATED TACK DRIVER
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
GXN  
Date Received05/02/2002
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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