COOL-TEC ELECTRODES
FDA 510(k) clearance K002841 · decided 2000-12-08
Clearance details
- K-number
- K002841
- Device name
- COOL-TEC ELECTRODES
- Applicant
- Seedling Enterprises., LLC
- Decision
- Substantially Equivalent
- Date received
- 2000-09-12
- Decision date
- 2000-12-08
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ayer, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.