MAMMOSITE MULTI LUMEN
FDA 510(k) clearance K092405 · decided 2009-08-27
Clearance details
- K-number
- K092405
- Device name
- MAMMOSITE MULTI LUMEN
- Applicant
- Hologic, Inc.
- Decision
- Unknown
- Date received
- 2009-08-06
- Decision date
- 2009-08-27
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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