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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K922648
Device Name ACE CUSTOM SURGICAL PACK
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Applicant Contact JOAO R QUINTINO
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Correspondent Contact JOAO R QUINTINO
Regulation Number878.4370
Classification Product Code
LRO  
Date Received06/03/1992
Decision Date 03/20/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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