The following data is part of a premarket notification filed by Intl. Medical Technologies, Inc. with the FDA for Diagnostic Dilatation & Menstrual Kit.
| Device ID | K840384 |
| 510k Number | K840384 |
| Device Name: | DIAGNOSTIC DILATATION & MENSTRUAL KIT |
| Classification | System, Abortion, Vacuum |
| Applicant | INTL. MEDICAL TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-30 |
| Decision Date | 1984-04-30 |