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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K970971
Device Name URO MED NERVE STIMULATOR
Applicant
UROMED CORP.
64 A ST.
NEEDHAM,  MA  02194
Applicant Contact FREDERICK TOBIA
Correspondent
UROMED CORP.
64 A ST.
NEEDHAM,  MA  02194
Correspondent Contact FREDERICK TOBIA
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
FGM  
Date Received03/17/1997
Decision Date 10/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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