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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pusher, Socket
510(k) Number K885305
Device Name ACETABULAR CUP PUSHER/IMPACTOR
Applicant
Cobot Medical Corp.
P.O. Box 9216
Paramus,  NJ  07653
Applicant Contact JACK QUINN
Correspondent
Cobot Medical Corp.
P.O. Box 9216
Paramus,  NJ  07653
Correspondent Contact JACK QUINN
Regulation Number888.4540
Classification Product Code
HXO  
Date Received12/27/1988
Decision Date 02/08/1989
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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