Prestige Ameritech Pediatric/Childs Face mask— 510(k) K160100
Substantially EquivalentPrestige Ameritech
FDA 510(k) clearance K160100 for Prestige Ameritech Pediatric/Childs Face mask, Substantially Equivalent on 2016-10-07. Applicant: Prestige Ameritech. Device class: 2.
Clearance details
- Applicant
- Prestige Ameritech
- 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
- North Richland Hills, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.