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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 K951392
Device Name MINIBONEPLATE SYSTEM
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 Number872.4760
Classification Product Code
JEY  
Date Received03/21/1995
Decision Date 05/05/1995
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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