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FDA 510(k) Application Details - K094028
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K094028
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
CP MEDICAL
803 NE 25TH AVE.
PORTLAND, OR 97232 US
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Contact
BARBARA K HORTON
Other 510(k) Applications for this Contact
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
12/30/2009
Decision Date
03/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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