SUN-LITE BLUE SPOT
FDA 510(k) clearance K840427 · decided 1984-05-09
Clearance details
- K-number
- K840427
- Device name
- SUN-LITE BLUE SPOT
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-31
- Decision date
- 1984-05-09
- Days to decision
- 99 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.