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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bougie, esophageal, and gastrointestinal, gastro-urology
510(k) Number K960173
Device Name INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
Applicant
GABRIEL MEDICAL, INC.
ATTN: MARY M. MCNAMARA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
GABRIEL MEDICAL, INC.
ATTN: MARY M. MCNAMARA
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number876.5365
Classification Product Code
FAT  
Subsequent Product Code
FQP  
Date Received01/16/1996
Decision Date 06/27/1996
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
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