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FDA 510(k) Application Details - K102092
Device Classification Name
Respirator,Surgical
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510(K) Number
K102092
Device Name
Respirator,Surgical
Applicant
Prestige Ameritech
7201 Iron Horse Blvd
North Richland Hills, TX 76180 US
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Contact
BARARA MCCARTY
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Regulation Number
878.4040
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Classification Product Code
MSH
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More FDA Info for this Product Code
Date Received
07/27/2010
Decision Date
10/06/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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