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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Fiberoptic
510(k) Number K964561
Device Name ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
Applicant
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact KEITH LOWREY
Correspondent
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact KEITH LOWREY
Regulation Number876.4530
Classification Product Code
FDG  
Subsequent Product Code
HJM  
Date Received11/13/1996
Decision Date 02/11/1997
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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