DERMATHERAPY, MODEL 22216
FDA 510(k) clearance K061242 · decided 2007-01-25
Clearance details
- K-number
- K061242
- Device name
- DERMATHERAPY, MODEL 22216
- Applicant
- Precision Fabrics Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-03
- Decision date
- 2007-01-25
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- FMW
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Norfolk, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.