The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Iui Set For Intrauterine Insemination.
| Device ID | K940176 |
| 510k Number | K940176 |
| Device Name: | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-11 |
| Decision Date | 1996-04-23 |
| Summary: | summary |