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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 K880331
Device Name HOOK PUNCH FORCEPS FOR ARTHROSCOPY
Applicant
Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.
60 E. 42 St.
New York,  NY  10165
Applicant Contact ODED BIRAN
Correspondent
Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.
60 E. 42 St.
New York,  NY  10165
Correspondent Contact ODED BIRAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/26/1988
Decision Date 02/18/1988
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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