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FDA 510(k) Application Details - K070782
Device Classification Name
Respirator,Surgical
More FDA Info for this Device
510(K) Number
K070782
Device Name
Respirator,Surgical
Applicant
SURVIVAIR RESPIRATORS, LLC
1025 W. EVERETT RD.
LAKE FOREST, IL 60045 US
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Contact
RICHARD O WOOD
Other 510(k) Applications for this Contact
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
03/21/2007
Decision Date
04/11/2007
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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