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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name knife, orthopedic
510(k) Number K873714
Device Name BANANA KNIFE, DISPOSABLE #TM-1612
Original Applicant
ARTHROPEDICS, INC.
111 lester st.
wallington,  NJ  07057
Original Contact jerry procopio
Regulation Number888.4540
Classification Product Code
HTS  
Date Received09/15/1987
Decision Date 11/02/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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