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FDA 510(k) Application Details - K955808
Device Classification Name
Cabinet, Moist Steam
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510(K) Number
K955808
Device Name
Cabinet, Moist Steam
Applicant
THERMIA, INC.
4200 WEST 76TH ST.
EDINA, MN 55435 US
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Contact
STEVEN J DAFFER
Other 510(k) Applications for this Contact
Regulation Number
890.5250
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Classification Product Code
IMB
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More FDA Info for this Product Code
Date Received
12/22/1995
Decision Date
11/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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