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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 K041732
Device Name CAVERMAP SURGICAL AID
Applicant
BLUE TORCH MEDICAL TECHNOLOGIES
200 HOMER AVE ASHLAND TECH.
CENTER
ASHLAND,  MA  01721
Applicant Contact FREDERICK TOBIA
Correspondent
BLUE TORCH MEDICAL TECHNOLOGIES
200 HOMER AVE ASHLAND TECH.
CENTER
ASHLAND,  MA  01721
Correspondent Contact FREDERICK TOBIA
Regulation Number876.4730
Classification Product Code
FGM  
Subsequent Product Code
ETN  
Date Received06/25/2004
Decision Date 09/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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