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FDA 510(k) Application Details - K963220
Device Classification Name
Pack, Hot Or Cold, Disposable
More FDA Info for this Device
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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More FDA Info for this Product Code
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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