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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K864459
Device Name RAIL CLAMP EXTENSION PIECE
Applicant
American Container Technology, Inc.
111 Lester St.
Wallington,  NJ  07057
Applicant Contact HERBERT SCHAINHOLZ
Correspondent
American Container Technology, Inc.
111 Lester St.
Wallington,  NJ  07057
Correspondent Contact HERBERT SCHAINHOLZ
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received11/12/1986
Decision Date 12/01/1986
Decision Substantially Equivalent (SESE)
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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