The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Laser Surgical Rod.
| Device ID | K862815 |
| 510k Number | K862815 |
| Device Name: | LASER SURGICAL ROD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
| Contact | Mike Barbour |
| Correspondent | Mike Barbour LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-24 |
| Decision Date | 1986-11-17 |