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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K860582
Device Name TBI NEEDLE
Applicant
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Applicant Contact STEVEN G RICHTER
Correspondent
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Correspondent Contact STEVEN G RICHTER
Regulation Number878.4800
Classification Product Code
GAA  
Date Received02/18/1986
Decision Date 03/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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