FDA 510(k) Application Details - K963220

Device Classification Name Pack, Hot Or Cold, Disposable

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510(K) Number K963220
Device Name Pack, Hot Or Cold, Disposable
Applicant TEMPO TECHNOLOGY, INC.
5945 NORTH WASHINGTON BLVD.
SARASOTA, FL 34243 US
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Contact JAY RUEHLEN
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Regulation Number 890.5710

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Classification Product Code IMD
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Date Received 08/16/1996
Decision Date 10/10/1996
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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