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FDA 510(k) Application Details - K132949
Device Classification Name
More FDA Info for this Device
510(K) Number
K132949
Device Name
PELLEFIRM
Applicant
ELLMAN INTERNATIONAL, INC.
400 KARIN LANE
HICKSVILLE, NY 11801 US
Other 510(k) Applications for this Company
Contact
Alison Sathe
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2013
Decision Date
02/20/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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