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FDA 510(k) Application Details - K050355
Device Classification Name
More FDA Info for this Device
510(K) Number
K050355
Device Name
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
Applicant
TISSUE SCIENCE LABORATORIES, PLC
1141 CLARK STREET, SUITE D
COVINGTON, GA 30014 US
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Contact
VICTORIA TAYLOR
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Regulation Number
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Classification Product Code
PAI
Other 510(k) Applications for this Device
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Date Received
02/14/2005
Decision Date
03/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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