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FDA 510(k) Application Details - K093179
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K093179
Device Name
Mask, Surgical
Applicant
H&H RESEARCH COMPANY
1245 WILSHIRE BLVD. #501
LOS ANGELES, CA 90017 US
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Contact
JONG HUANG
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FXX
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More FDA Info for this Product Code
Date Received
10/08/2009
Decision Date
07/14/2010
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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