FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PRIMED Pediatric Facemask
K Number: K213427
·
Decision Nov 22, 2022
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
3
Review Days
397
Basic Information
- Device Name
- PRIMED Pediatric Facemask
- K Number
- K213427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PRIMED Medical Products Inc.
- Date Received
- October 21, 2021
- Decision Date
- November 22, 2022
- Product Code
- OXZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXZ | Pediatric/Child Facemask | FDA class 2 | General, Plastic Surgery |
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