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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 K872270
Device Name ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
Applicant
Orthoconcept, Inc.
8 Cold Branch Ct.
Columbia,  SC  29223
Applicant Contact JACK DEFRANCO
Correspondent
Orthoconcept, Inc.
8 Cold Branch Ct.
Columbia,  SC  29223
Correspondent Contact JACK DEFRANCO
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/12/1987
Decision Date 07/21/1987
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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