The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurz Upper Eyelid Implant Sizers, Model 8000 111.
| Device ID | K001123 |
| 510k Number | K001123 |
| Device Name: | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 |
| Classification | Weights, Eyelid, External |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-07 |
| Decision Date | 2000-04-21 |