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FDA 510(k) Application Details - K970448
Device Classification Name
Respirator,Surgical
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510(K) Number
K970448
Device Name
Respirator,Surgical
Applicant
TECNOL MEDICAL PRODUCTS, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH, TX 76180 US
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Contact
RUTH JONES
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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
02/06/1997
Decision Date
04/30/1997
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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