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FDA 510(k) Application Details - K083629
Device Classification Name
Massager, Vacuum, Light Induced Heating
More FDA Info for this Device
510(K) Number
K083629
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
ELEME MEDICAL, INC.
HERON COVE OFFICE PARK
10 AL PAUL LANE, SUITE 102
MERRIMACK, NH 03054 US
Other 510(k) Applications for this Company
Contact
MICHAIL PANKRATOV
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NUV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/08/2008
Decision Date
02/19/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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