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FDA 510(k) Application Details - K113763
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K113763
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 Newhope St
Fountain Valley, CA 92708 US
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Contact
MARIA HATEGAN
Other 510(k) Applications for this Contact
Regulation Number
878.5010
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Classification Product Code
GAW
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More FDA Info for this Product Code
Date Received
12/21/2011
Decision Date
03/16/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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