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FDA 510(k) Application Details - K060340
Device Classification Name
Oral Wound Dressing
More FDA Info for this Device
510(K) Number
K060340
Device Name
Oral Wound Dressing
Applicant
MPM MEDICAL, INC.
897 CHANCERY CT
MONROE, MI 48161 US
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Contact
RICHARD A HAMER
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OLR
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More FDA Info for this Product Code
Date Received
02/10/2006
Decision Date
05/10/2006
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
FDA Source Information for K060340
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