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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Non-Electric
510(k) Number K922396
Device Name FUJINON FORCEPS -- MODIFICATION
Applicant
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Applicant Contact ROB WHALEN
Correspondent
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Correspondent Contact ROB WHALEN
Regulation Number876.1075
Classification Product Code
FCL  
Date Received05/19/1992
Decision Date 12/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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