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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 K873650
Device Name C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-1360
Applicant
Arthropedics, Inc.
111 Lester St.
Wallington,  NJ  07057
Applicant Contact JERRY PROCOPIO
Correspondent
Arthropedics, Inc.
111 Lester St.
Wallington,  NJ  07057
Correspondent Contact JERRY PROCOPIO
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/10/1987
Decision Date 11/02/1987
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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