510(k) K870790
K870790 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000". The FDA issued a decision of Substantially Equivalent on April 1, 1987. The device falls under product code FTX (Mirror, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1987
- Date Received
- February 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mirror, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type