The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Modified Hysterosalpingograpy Set.
| Device ID | K871069 |
| 510k Number | K871069 |
| Device Name: | MODIFIED HYSTEROSALPINGOGRAPY SET |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman,phd |
| Correspondent | Bernard Ackerman,phd ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-04-06 |