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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K051381
Device Name ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
Brockton,  MA  02301
Applicant Contact J. EDWARD CARCHIDI
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
Brockton,  MA  02301
Correspondent Contact J. EDWARD CARCHIDI
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/27/2005
Decision Date 07/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
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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