SOOTHIES GEL PADS— 510(k) K052858
Substantially EquivalentPuronxy, Inc.
FDA 510(k) clearance K052858 for SOOTHIES GEL PADS, Substantially Equivalent on 2006-02-09. Applicant: Puronxy, Inc.. Device class: 1.
Clearance details
- Applicant
- Puronxy, Inc.
- Product code
- Code NXH
- Device class
- Class 1
- Regulation
- 21 CFR 880.5630
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.