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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K864476
Device Name LEG HOLDER
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 Number888.1100
Classification Product Code
HRX  
Date Received11/13/1986
Decision Date 12/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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