The following data is part of a premarket notification filed by Inntec, Inc. with the FDA for Embryo Transfer Catheter With Accessory Stylet, Models 9018, 9023, 9018-s, 9023-s.
| Device ID | K050521 |
| 510k Number | K050521 |
| Device Name: | EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S |
| Classification | Catheter, Assisted Reproduction |
| Applicant | INNTEC, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring INNTEC, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-05-02 |
| Summary: | summary |