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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral
510(k) Number K945088
Device Name GABRIEL URETERAL ILLUMINATOR SYSTEM II
Applicant
GABRIEL MEDICAL, INC.
ATTN: MARY M. MCNAMARA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY M MCNAMARA
Correspondent
GABRIEL MEDICAL, INC.
ATTN: MARY M. MCNAMARA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY M MCNAMARA
Regulation Number876.4020
Classification Product Code
FCS  
Date Received10/17/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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