FDA 510(k) Application Details - K011768

Device Classification Name Unit, Fluidotherapy

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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
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Regulation Number 000.0000

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Classification Product Code LSB
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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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