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FDA 510(k) Application Details - K163556
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K163556
Device Name
Drape, Surgical
Applicant
COVALON TECHNOLOGIES, INC.
1660 TECH AVENUE
UNIT 5
MISSISSSAUGA L4W 5S7 CA
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Contact
KIM CROOKS
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
12/19/2016
Decision Date
09/14/2017
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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