Submission Details
| 510(k) Number | K083008 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2008 |
| Decision Date | June 10, 2009 |
| Days to Decision | 245 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Abbreviated
COOLSKIN
Jun 2009
Decision
245d
Days
Class 2
Risk
About This 510(k) Submission
K083008 is an FDA 510(k) clearance for the COOLSKIN, a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO), submitted by Elbio Co., Ltd. (Roswell, US). The FDA issued a Cleared decision on June 10, 2009, 245 days after receiving the submission on October 8, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5720.
Device Classification
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5720 |
Manufacturer
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