LINISTAIN SLS
FDA 510(k) clearance K890984 · decided 1989-04-04
Clearance details
- K-number
- K890984
- Device name
- LINISTAIN SLS
- Applicant
- Shandon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-27
- Decision date
- 1989-04-04
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KIO
- Device class
- 1
- Regulation number
- 864.3800
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.