The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Laser Trap 100 Laser Plume Smoke Evacuation Filter.
Device ID | K902056 |
510k Number | K902056 |
Device Name: | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER |
Classification | Evacuator, Vapor, Cement Monomer |
Applicant | HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
Contact | John F Lemker |
Correspondent | John F Lemker HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
Product Code | JDY |
CFR Regulation Number | 888.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-07 |
Decision Date | 1990-10-30 |