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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K850785
Device Name FASTUBE NERVE REGENERATION DEVICE
Applicant
RESEARCH MEDICAL, INC.
1847 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
RESEARCH MEDICAL, INC.
1847 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number882.5275
Classification Product Code
JXI  
Date Received02/26/1985
Decision Date 07/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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