SINGUL-XR RP NON SCREEN MED. FILM— 510(k) K834611
Substantially EquivalentCea America Corp.
FDA 510(k) clearance K834611 for SINGUL-XR RP NON SCREEN MED. FILM, Substantially Equivalent on 1984-02-21. Applicant: Cea America Corp.. Device class: 1.
Clearance details
- Applicant
- Cea America Corp.
- Product code
- Code IWZ
- Device class
- Class 1
- Regulation
- 21 CFR 892.1840
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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