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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K970107
FOIA Releasable 510(k) K970107
Device Name INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
Applicant
UROHEALTH SYSTEMS, INC.
3050 REDHILL AVE.
COSTA MESA,  CA  92626
Applicant Contact RONALD H BERGESON
Correspondent
UROHEALTH SYSTEMS, INC.
3050 REDHILL AVE.
COSTA MESA,  CA  92626
Correspondent Contact RONALD H BERGESON
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/13/1997
Decision Date 11/18/1997
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
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