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 |