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FDA 510(k) Application Details - K972410
Device Classification Name
Gown, Isolation, Surgical
More FDA Info for this Device
510(K) Number
K972410
Device Name
Gown, Isolation, Surgical
Applicant
KENTRON HEALTH CARE, INC.
3604 KELTON JACKSON ROAD
SPRINGFIELD, TN 37172 US
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Contact
NARI SADARANGANI
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYC
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More FDA Info for this Product Code
Date Received
06/26/1997
Decision Date
09/19/1997
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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