SATURN ACTIVE LASER SYSTEM
FDA 510(k) clearance K083208 · decided 2009-08-25
Clearance details
- K-number
- K083208
- Device name
- SATURN ACTIVE LASER SYSTEM
- Applicant
- Research Instruments , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-31
- Decision date
- 2009-08-25
- Days to decision
- 298 days
- Clearance type
- Abbreviated
- Product code
- MRX
- Device class
- 2
- Regulation number
- 884.6200
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Falmouth, Cornwall, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.