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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Tangent, Projection, Battery-Powered
510(k) Number K934084
Device Name BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
Applicant
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact DAVID D WELLINGTON
Correspondent
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact DAVID D WELLINGTON
Regulation Number886.1810
Classification Product Code
HMJ  
Date Received08/20/1993
Decision Date 12/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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