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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, eye movement, diagnostic
510(k) Number K931678
Device Name ORTHOMET LHMC FEMORAL STEM
Applicant
ORTHOMET, INC.
6301 CECILIA CIRCLE
MINNEAPOLIS,  MN  55439 -2713
Applicant Contact DAVID A CANNISTRACI
Correspondent
ORTHOMET, INC.
6301 CECILIA CIRCLE
MINNEAPOLIS,  MN  55439 -2713
Correspondent Contact DAVID A CANNISTRACI
Regulation Number886.1510
Classification Product Code
HMC  
Date Received04/06/1993
Decision Date 10/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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