510(k) K072152

JUNIPER CLN1 DERMAL COOLING DEVICE by Juniper Medical, Inc. — Product Code ILO

K072152 is an FDA 510(k) premarket notification submitted by Juniper Medical, Inc. for the device "JUNIPER CLN1 DERMAL COOLING DEVICE". The FDA issued a decision of Substantially Equivalent on September 7, 2007. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Juniper Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2007
Date Received
August 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type