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FDA 510(k) Application Details - K053225
Device Classification Name
Massager, Therapeutic, Electric
More FDA Info for this Device
510(K) Number
K053225
Device Name
Massager, Therapeutic, Electric
Applicant
LPG ONE, INC
845 ARONSON LAKE COURT
ROSWELL, GA 30075 US
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Contact
JAY MANSOUR
Other 510(k) Applications for this Contact
Regulation Number
890.5660
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Classification Product Code
ISA
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More FDA Info for this Product Code
Date Received
11/17/2005
Decision Date
11/06/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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