The following data is part of a premarket notification filed by Pacific Ophthalmic Supply with the FDA for Model Sl-yz5e.
Device ID | K962522 |
510k Number | K962522 |
Device Name: | MODEL SL-YZ5E |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | PACIFIC OPHTHALMIC SUPPLY 1920 OAK KNOLL DR. Belmont, CA 94002 |
Contact | Will Markle |
Correspondent | Will Markle PACIFIC OPHTHALMIC SUPPLY 1920 OAK KNOLL DR. Belmont, CA 94002 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-14 |
Decision Date | 1996-07-25 |