FDA 510(k) Application Details - K021843

Device Classification Name Pack, Hot Or Cold, Disposable

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510(K) Number K021843
Device Name Pack, Hot Or Cold, Disposable
Applicant BIO-LIPID, INC.
1301 K STREET, N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact DAVID J BLOCH
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Regulation Number 890.5710

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Classification Product Code IMD
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Date Received 06/05/2002
Decision Date 09/03/2002
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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