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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral, Gastro-Urology
510(k) Number K914358
Device Name ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP
Applicant
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Applicant Contact ROBERT G WHALEN
Correspondent
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Correspondent Contact ROBERT G WHALEN
Regulation Number876.5130
Classification Product Code
EYB  
Date Received10/01/1991
Decision Date 11/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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