The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Intrauterine Insemination And Sonohysterography Catheter.
| Device ID | K970492 |
| 510k Number | K970492 |
| Device Name: | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman, Ph.d. |
| Correspondent | Bernard Ackerman, Ph.d. ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937016394 | K970492 | 000 |