ISO-GARD MASK— 510(k) K142138
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K142138 for ISO-GARD MASK, Substantially Equivalent on 2014-10-30. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code CBN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5430
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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