510(k) K072152
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