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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K993445
Device Name OMNISONIC ENDOSCOPIC DEFLECTOR
Applicant
OMNISONICS MEDICAL TECHNOLOGIES
7 TIFFANY TRAIL
HOPKONTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
OMNISONICS MEDICAL TECHNOLOGIES
7 TIFFANY TRAIL
HOPKONTON,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number876.1500
Classification Product Code
GCM  
Date Received10/12/1999
Decision Date 12/06/1999
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
Predetermined Change
Control Plan Authorized		 No
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