The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Mi-mark Endocervical Sampling Set.
| Device ID | K790923 |
| 510k Number | K790923 |
| Device Name: | MI-MARK ENDOCERVICAL SAMPLING SET |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | SIMPSON/BASYE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-15 |
| Decision Date | 1979-06-22 |