The following data is part of a premarket notification filed by Inntec, Inc. with the FDA for Oocyte Retrieval Needle Set, Models 917-ih And 917-sh.
| Device ID | K051742 |
| 510k Number | K051742 |
| Device Name: | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH |
| Classification | Needle, 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 | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-10-07 |
| Summary: | summary |