The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for 904 Slit Lamp.
| Device ID | K953965 |
| 510k Number | K953965 |
| Device Name: | 904 SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Contact | Michael J Wilkinson |
| Correspondent | Michael J Wilkinson CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060179470313 | K953965 | 000 |
| 05060179470276 | K953965 | 000 |