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FDA 510(k) Application Details - K061227
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K061227
Device Name
Dressing, Wound, Drug
Applicant
THE HYMED GROUP CORP.
1890 BUCKNELL DR.
BETHLEHEM, PA 18015 US
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Contact
ANITA PETITO
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
05/02/2006
Decision Date
12/20/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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