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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K942032
Device Name PLAMP, PLAMP PLATE, PLAMP WITH HOOK
Applicant
Hospital For Special Surgery
535 E. 70th St.
New York,  NY  10021
Applicant Contact BRUCE H ROBIE
Correspondent
Hospital For Special Surgery
535 E. 70th St.
New York,  NY  10021
Correspondent Contact BRUCE H ROBIE
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/26/1994
Decision Date 06/13/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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