510(k) K071710

BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) by Johnson & Johnson Consumer Products, Inc. — Product Code IMD

K071710 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Consumer Products, Inc. for the device "BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)". The FDA issued a decision of Substantially Equivalent on August 14, 2007. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Johnson & Johnson Consumer Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2007
Date Received
June 22, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type