The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurz Pure Gold Upper Eyelids Implant (oberascher), Model 4001 02-4001 10.
| Device ID | K000127 |
| 510k Number | K000127 |
| Device Name: | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 |
| Classification | Weights, Eyelid, External |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar 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 | 2000-01-18 |
| Decision Date | 2000-04-12 |