OTP 1.2— 510(k) K031349
Substantially EquivalentNucletron Corp.
FDA 510(k) clearance K031349 for OTP 1.2, Substantially Equivalent on 2003-08-07. Applicant: Nucletron Corp.. Device class: 2.
Clearance details
- Applicant
- Nucletron Corp.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Columbia, MD, US
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