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FDA 510(k) Application Details - K012199
Device Classification Name
Needle, Suturing, Disposable
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510(K) Number
K012199
Device Name
Needle, Suturing, Disposable
Applicant
HUMANA USA, INC.
8309 BRYANT DR.
BETHESDA, MD 20817 US
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Contact
H.N. DUNNING
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
GAB
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More FDA Info for this Product Code
Date Received
07/13/2001
Decision Date
12/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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