GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
FDA 510(k) clearance K983436 · decided 1998-10-29
Clearance details
- K-number
- K983436
- Device name
- GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
- Applicant
- Gammamed USA
- Decision
- Substantially Equivalent
- Date received
- 1998-09-29
- Decision date
- 1998-10-29
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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