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FDA 510(k) Application Details - K141876
Device Classification Name
Respirator,Surgical
More FDA Info for this Device
510(K) Number
K141876
Device Name
Respirator,Surgical
Applicant
PASTURE PHARMA PTE LTD
38129 SPRING CANYON DRIVE
MURRIETA, CA 92563 US
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Contact
SARAH HASSAN
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
MSH
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More FDA Info for this Product Code
Date Received
07/11/2014
Decision Date
10/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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