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FDA 510(k) Application Details - K092533
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K092533
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF
5307 95TH AVE.
KENOSHA, WI 53144 US
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Contact
JOY VOIGT
Other 510(k) Applications for this Contact
Regulation Number
878.5000
More FDA Info for this Regulation Number
Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
08/19/2009
Decision Date
09/15/2009
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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