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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 K990140
Device Name NORMED BONE TRANSPORT
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Applicant Contact J. EDWARD CARCHIDI
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Correspondent Contact J. EDWARD CARCHIDI
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/19/1999
Decision Date 03/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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