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FDA 510(k) Application Details - K990332
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K990332
Device Name
Dressing, Wound, Drug
Applicant
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
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Contact
SHARMINI ATHERAY
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Regulation Number
000.0000
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Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
02/03/1999
Decision Date
04/14/1999
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K990332
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