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FDA 510(k) Application Details - K041159
Device Classification Name
Staple, Implantable
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510(K) Number
K041159
Device Name
Staple, Implantable
Applicant
JMS, INC.
1221 1ST STREET SOUTH
# 7A
JACKSONVILLE BEACH, FL 32250 US
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Contact
JOHN I SHIPP
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
05/03/2004
Decision Date
07/27/2004
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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