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FDA 510(k) Application Details - K071710
Device Classification Name
Pack, Hot Or Cold, Disposable
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
DAGMAR OETTE
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
06/22/2007
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
FDA Source Information for K071710
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