The following data is part of a premarket notification filed by Labotect Labor-technik Gottingen with the FDA for Embryo Transfer Catheter Set, Model 320200 And 320201.
| Device ID | K000950 |
| 510k Number | K000950 |
| Device Name: | EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 |
| Classification | Catheter, Assisted Reproduction |
| Applicant | LABOTECT LABOR-TECHNIK GOTTINGEN WILLI-EICHLER-STR. 25 Gottingen, DE D-37079 |
| Contact | Angelika Albrecht |
| Correspondent | Angelika Albrecht LABOTECT LABOR-TECHNIK GOTTINGEN WILLI-EICHLER-STR. 25 Gottingen, DE D-37079 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046668002259 | K000950 | 000 |
| 04046668003065 | K000950 | 000 |
| 04046668001412 | K000950 | 000 |
| 04046668001405 | K000950 | 000 |
| 04046668001429 | K000950 | 000 |