510(k) K070467
- Device
- HEALTH MASK
- Applicant
- POLAR WRAP LLC
- 510(k) number
- K070467
- Product code
- OBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-17
- Date received
- 2007-02-16
- Regulation
- 868.5450
- Classification name
- Humidifier, Respiratory, Mask (direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- PAUL DRYDEN
- Address
- 3460 Pt.e Creek Ct. #102 Bonita Springs FL US 34134 34134
Source Documents
Legacy Summary
summary
FDA Review
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