SOOTHIES GEL PADS
FDA 510(k) clearance K052858 · decided 2006-02-09
Clearance details
- K-number
- K052858
- Device name
- SOOTHIES GEL PADS
- Applicant
- Puronxy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-11
- Decision date
- 2006-02-09
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- NXH
- Device class
- 1
- Regulation number
- 880.5630
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.