The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire.
| Device ID | K071150 |
| 510k Number | K071150 |
| Device Name: | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE |
| Classification | Tube, Tympanostomy |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-1 Amsterdam, NL D-72144 |
| Contact | Dagmar Maeser |
| Correspondent | Dagmar Maeser HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-1 Amsterdam, NL 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 | 2007-04-25 |
| Decision Date | 2007-12-12 |
| Summary: | summary |