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FDA 510(k) Application Details - K850535
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K850535
Device Name
Dressing, Wound, Drug
Applicant
MITRAL MEDICAL LTD.
4070 YOUNGFIELD ST.
WHEAT RIDGE, CO US
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Contact
RENA E TODD
Other 510(k) Applications for this Contact
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
02/11/1985
Decision Date
06/05/1985
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
-
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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