REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
FDA 510(k) clearance K870790 · decided 1987-04-01
Clearance details
- K-number
- K870790
- Device name
- REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
- Applicant
- Lifestream Int'L, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-26
- Decision date
- 1987-04-01
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- FTX
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.