The following data is part of a premarket notification filed by Microtech, Inc. with the FDA for Bartell Small Incision Lens Glide.
| Device ID | K854994 |
| 510k Number | K854994 |
| Device Name: | BARTELL SMALL INCISION LENS GLIDE |
| Classification | Lens, Guide, Intraocular |
| Applicant | MICROTECH, INC. 2867 MILL RD. Doylestown, PA 18901 |
| Contact | Michael Bartell |
| Correspondent | Michael Bartell MICROTECH, INC. 2867 MILL RD. Doylestown, PA 18901 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-02-04 |