The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Reflective Mirror/co2 Laser Surg Cat. #902002-000.
Device ID | K870790 |
510k Number | K870790 |
Device Name: | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 |
Classification | Mirror, General & Plastic Surgery |
Applicant | LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
Contact | Roger Mogill |
Correspondent | Roger Mogill LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
Product Code | FTX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-04-01 |