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FDA 510(k) Application Details - K021843
Device Classification Name
Pack, Hot Or Cold, Disposable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5710
More FDA Info for this Regulation Number
Classification Product Code
IMD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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