COOLSKIN
FDA 510(k) clearance K083008 · decided 2009-06-10
Clearance details
- K-number
- K083008
- Device name
- COOLSKIN
- Applicant
- Elbio Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-08
- Decision date
- 2009-06-10
- Days to decision
- 245 days
- Clearance type
- Abbreviated
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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| BLEDSOE COLD CONTROL (K964710) | Med Technology, Inc. | 1997-05-09 |
| MODEL 1100 COLD THERAPY DEVICE (K970533) | Smith & Nephew, Inc. | 1997-04-15 |
| STERILE SOFT-TEMP (K962983) | Adroit Medical Systems, Inc. | 1997-01-10 |
Recalls involving this device
No recalls on record reference this clearance.