HDR CT COMPATIBLE SPLIT RING APPLICATOR
FDA 510(k) clearance K063382 · decided 2006-12-26
Clearance details
- K-number
- K063382
- Device name
- HDR CT COMPATIBLE SPLIT RING APPLICATOR
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-08
- Decision date
- 2006-12-26
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mt. Vernon, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.