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 |