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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K961071
Device Name THE MAGNUM CHIN IMPLANT
Applicant
RAND SCIENTIFIC CORP.
4135 NORTHGATE BLVD.
SUITE 9
SACRAMENTO,  CA  95834
Applicant Contact DUANE TRACY
Correspondent
RAND SCIENTIFIC CORP.
4135 NORTHGATE BLVD.
SUITE 9
SACRAMENTO,  CA  95834
Correspondent Contact DUANE TRACY
Regulation Number878.3550
Classification Product Code
FWP  
Date Received03/18/1996
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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