BURLEW INFANT HOOD— 510(k) K962182
Substantially EquivalentPromedic, Inc.
FDA 510(k) clearance K962182 for BURLEW INFANT HOOD, Substantially Equivalent on 1996-07-15. Applicant: Promedic, Inc.. Device class: 1.
Clearance details
- Applicant
- Promedic, Inc.
- Product code
- Code FOG
- Device class
- Class 1
- Regulation
- 21 CFR 868.5700
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mccordsville, IN, US
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