LSU 2000 PORTABLE SUCTION UNIT
FDA 510(k) clearance K950698 · decided 1995-05-09
Clearance details
- K-number
- K950698
- Device name
- LSU 2000 PORTABLE SUCTION UNIT
- Applicant
- Laerdal Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-10
- Decision date
- 1995-05-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Armonk, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.