HEALTH MASK— 510(k) K070467
Substantially EquivalentPolar Wrap, LLC
FDA 510(k) clearance K070467 for HEALTH MASK, Substantially Equivalent on 2007-04-17. Applicant: Polar Wrap, LLC. Device class: 2.
Clearance details
- Applicant
- Polar Wrap, LLC
- Product code
- Code OBN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.