The following data is part of a premarket notification filed by Heinz Kurz with the FDA for Titanium Vocal Fold Medializing Implant, Models 5001 001 (female), And 5001 003 (male).
| Device ID | K991324 |
| 510k Number | K991324 |
| Device Name: | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM50010031 | K991324 | 000 |
| EHKM50010011 | K991324 | 000 |
| EHKM50010001 | K991324 | 000 |