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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe And Director, Gastro-Urology
510(k) Number K010098
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 Number876.4730
Classification Product Code
FGM  
Date Received01/11/2001
Decision Date 02/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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