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FDA 510(k) Application Details - K992604
Device Classification Name
Mask, Surgical
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510(K) Number
K992604
Device Name
Mask, Surgical
Applicant
MITSUI TEXTILE CORP.
1450 BROADWAY
NEW YORK, NY 10018 US
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Contact
WILLIAM J BARONE
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
08/03/1999
Decision Date
01/28/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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