PRIMED Pediatric Facemask— 510(k) K213427
Substantially EquivalentPrimed Medical Products, Inc.
FDA 510(k) clearance K213427 for PRIMED Pediatric Facemask, Substantially Equivalent on 2022-11-22. Applicant: Primed Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primed Medical Products, Inc.
- Product code
- Code OXZ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.