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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Holder
510(k) Number K992006
Device Name NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
Applicant
Integra Neurocare, LLC
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact NANCY A MATHEWSON
Correspondent
Integra Neurocare, LLC
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact NANCY A MATHEWSON
Regulation Number876.1500
Classification Product Code
OCV  
Date Received06/15/1999
Decision Date 08/17/1999
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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