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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 K924753
Device Name BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
Applicant
BIOENTERICS CORP.
1035 A CINDY LN.
CARPINTERIA,  CA  93013
Applicant Contact DELORES GRAHAM
Correspondent
BIOENTERICS CORP.
1035 A CINDY LN.
CARPINTERIA,  CA  93013
Correspondent Contact DELORES GRAHAM
Regulation Number886.1810
Classification Product Code
HMJ  
Date Received09/22/1992
Decision Date 12/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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