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FDA 510(k) Application Details - K980791
Device Classification Name
Gauze/Sponge, Internal
More FDA Info for this Device
510(K) Number
K980791
Device Name
Gauze/Sponge, Internal
Applicant
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
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Contact
SHARMINI ATHERAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
EFQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/1998
Decision Date
04/29/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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