K072152 is an FDA 510(k) clearance for the JUNIPER CLN1 DERMAL COOLING DEVICE. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Juniper Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 7, 2007, 35 days after receiving the submission on August 3, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K072152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2007 |
| Decision Date | September 07, 2007 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |