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FDA 510(k) Application Details - K130350
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K130350
Device Name
Dressing, Wound, Drug
Applicant
VOMARIS INNOVATIONS INC.
3100 W. Ray Rd, Ste 148
Chandler, AZ 85226 US
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Contact
Mary Maijer
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2013
Decision Date
07/02/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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