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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K871924
Device Name STERILIZATION TRAY, TMJ INSTRUMENT SET
Applicant
Arthropedics, Inc.
111 Lester St.
Wallington,  NJ  07057
Applicant Contact HERBERT SCHAINHOLZ
Correspondent
Arthropedics, Inc.
111 Lester St.
Wallington,  NJ  07057
Correspondent Contact HERBERT SCHAINHOLZ
Regulation Number878.4800
Classification Product Code
FSM  
Date Received05/18/1987
Decision Date 06/01/1987
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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