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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Cytology Brush
510(k) Number K893729
Device Name HOBBS MEDICAL MICROBIOLOGY BRUSH
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 Number876.1500
Classification Product Code
FDX  
Date Received05/17/1989
Decision Date 08/28/1989
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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