FDA 510(k) Application Details - K071710

Device Classification Name Pack, Hot Or Cold, Disposable

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510(K) Number K071710
Device Name Pack, Hot Or Cold, Disposable
Applicant JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
201 TABOR ROAD
MORRIS PLAINS, NJ 07950 US
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Contact DAGMAR OETTE
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Regulation Number 890.5710

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Classification Product Code IMD
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Date Received 06/22/2007
Decision Date 08/14/2007
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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