FDA 510(k) Application Details - K974190

Device Classification Name Pack, Hot Or Cold, Disposable

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510(K) Number K974190
Device Name Pack, Hot Or Cold, Disposable
Applicant CONSOLIDATED PRODUCTS & SERVICES, INC.
100-L MESSINA DR.
BRAINTREE, MA 02184 US
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Contact WAYNE KRITZMAN
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Regulation Number 890.5710

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Classification Product Code IMD
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Date Received 11/04/1997
Decision Date 11/19/1997
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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