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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, fixation, proximal femoral, implant
510(k) Number K780187
Device Name NAIL, MASSIE II
Applicant
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3030
Classification Product Code
JDO  
Date Received02/06/1978
Decision Date 03/15/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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