MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
FDA 510(k) clearance K000081 · decided 2000-12-19
Clearance details
- K-number
- K000081
- Device name
- MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
- Applicant
- Isotopes and Metals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-11
- Decision date
- 2000-12-19
- Days to decision
- 343 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Geneva, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.