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FDA 510(k) Application Details - K042038
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K042038
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
9109 COPENHAVER DRIVE
POTOMAC, MD 20854 US
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Contact
NORMAN F ESTRIN
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Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
07/29/2004
Decision Date
12/23/2004
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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