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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K951510
Device Name ACE BONE SCREW TACKING KIT
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Applicant Contact J. E CARCHIDI
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Correspondent Contact J. E CARCHIDI
Regulation Number872.4880
Classification Product Code
DZL  
Date Received04/03/1995
Decision Date 08/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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