The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes With Ene/s, Diabolo Tympanic Ventilation Tube, Minimal T).
| Device ID | K973226 |
| 510k Number | K973226 |
| Device Name: | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) |
| Classification | Tube, Tympanostomy |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-27 |
| Decision Date | 1997-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10150751 | K973226 | 000 |
| EHKM10150301 | K973226 | 000 |
| EHKM10150131 | K973226 | 000 |
| EHKM10150121 | K973226 | 000 |
| EHKM10150111 | K973226 | 000 |
| EHKM10150101 | K973226 | 000 |
| EHKM10150041 | K973226 | 000 |
| EHKM10150031 | K973226 | 000 |
| EHKM10150021 | K973226 | 000 |
| EHKM10150311 | K973226 | 000 |
| EHKM10150321 | K973226 | 000 |
| EHKM10150331 | K973226 | 000 |
| EHKM10150741 | K973226 | 000 |
| EHKM10150721 | K973226 | 000 |
| EHKM10150651 | K973226 | 000 |
| EHKM10150641 | K973226 | 000 |
| EHKM10150551 | K973226 | 000 |
| EHKM10150531 | K973226 | 000 |
| EHKM10150511 | K973226 | 000 |
| EHKM10150361 | K973226 | 000 |
| EHKM10150011 | K973226 | 000 |