The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Charcoal Laser Smoke Filter Catalog No. 901103-000.
| Device ID | K862509 |
| 510k Number | K862509 |
| Device Name: | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 |
| Classification | Evacuator, Vapor, Cement Monomer |
| Applicant | LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Contact | Mike Barbour |
| Correspondent | Mike Barbour LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Product Code | JDY |
| CFR Regulation Number | 888.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-23 |