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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 K091768
Device Name VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
Applicant
Vision-Sciences, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact LILLIAN QUINTERO
Correspondent
Vision-Sciences, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact LILLIAN QUINTERO
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/16/2009
Decision Date 08/03/2009
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
Predetermined Change
Control Plan Authorized		 No
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