The following data is part of a premarket notification filed by Medicult A/s with the FDA for Ism1+, Ims2+, And Utm+.
| Device ID | K030490 |
| 510k Number | K030490 |
| Device Name: | ISM1+, IMS2+, AND UTM+ |
| Classification | Media, Reproductive |
| Applicant | MEDICULT A/S P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi MEDICULT A/S P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-14 |
| Decision Date | 2003-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937801415 | K030490 | 000 |
| 00888937800555 | K030490 | 000 |