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FDA 510(k) Application Details - K011768
Device Classification Name
Unit, Fluidotherapy
More FDA Info for this Device
510(K) Number
K011768
Device Name
Unit, Fluidotherapy
Applicant
THERMO-ELECTRIC CO.
455 RT. 30
IMPERIAL, PA 15126 US
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Contact
LAWRENCE E MADSON
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LSB
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More FDA Info for this Product Code
Date Received
06/07/2001
Decision Date
08/03/2001
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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