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FDA 510(k) Application Details - K090092
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K090092
Device Name
Dressing, Wound, Drug
Applicant
MCMERLIN DENTAL PRODUCTS LP
1610 WEST POLO RD.
GRAND PRAIRIE, TX 75052 US
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Contact
AARON HENDERSHOTT
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
01/14/2009
Decision Date
05/11/2009
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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