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FDA 510(k) Application Details - K973379
Device Classification Name
Mesh, Surgical
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510(K) Number
K973379
Device Name
Mesh, Surgical
Applicant
S. JACKSON, INC.
15 ROTH ST.
P.O. BOX 4487
ALEXANDRIA, VA 22303 US
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Contact
J. JACKSON
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Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
09/08/1997
Decision Date
09/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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