The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Xe-lite.
Device ID | K954263 |
510k Number | K954263 |
Device Name: | XE-LITE |
Classification | Lamp, Surgical |
Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Contact | Rishard Weitz |
Correspondent | Rishard Weitz OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-12 |
Decision Date | 1995-10-18 |