The following data is part of a premarket notification filed by Eyetech M.v.a. with the FDA for Barraquer-krumeich Refractive Set.
| Device ID | K954058 |
| 510k Number | K954058 |
| Device Name: | BARRAQUER-KRUMEICH REFRACTIVE SET |
| Classification | Keratome, Ac-powered |
| Applicant | EYETECH M.V.A. EGERTA 53, POSTFACH 2 Fl-9496 Balzers, Liechtenstein, DE |
| Contact | E. Kaiser |
| Correspondent | E. Kaiser EYETECH M.V.A. EGERTA 53, POSTFACH 2 Fl-9496 Balzers, Liechtenstein, DE |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-11-06 |