LU-TEX II
FDA 510(k) clearance K904535 · decided 1991-01-30
Clearance details
- K-number
- K904535
- Device name
- LU-TEX II
- Applicant
- Lukens Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-04
- Decision date
- 1991-01-30
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- GAS
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rio Rancho, NM, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.