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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 K010213
Device Name MODIFICATION TO CAVERMAP SURGICAL AID
Applicant
UROMED CORP.
1400 PROVIDENCE HWY.
NORWOOD,  MA  02062
Applicant Contact FREDERICK TOBIA
Correspondent
UROMED CORP.
1400 PROVIDENCE HWY.
NORWOOD,  MA  02062
Correspondent Contact FREDERICK TOBIA
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
FGM  
Date Received01/23/2001
Decision Date 04/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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