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FDA 510(k) Application Details - K994313
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K994313
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY, MA 01915 US
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Contact
HOWARD L SCHRAYER
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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
12/22/1999
Decision Date
01/13/2000
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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