The following data is part of a premarket notification filed by Labotect Labor-technik Gottingen with the FDA for Insemination Catheter, Model 320301.
| Device ID | K021438 |
| 510k Number | K021438 |
| Device Name: | INSEMINATION CATHETER, MODEL 320301 |
| Classification | Cannula, Intrauterine Insemination |
| 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 | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-07-16 |
| Summary: | summary |