The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for Centauri.
Device ID | K905141 |
510k Number | K905141 |
Device Name: | CENTAURI |
Classification | Laser, Ophthalmic |
Applicant | PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
Contact | Colette Cozean |
Correspondent | Colette Cozean PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-15 |
Decision Date | 1991-02-11 |