The following data is part of a premarket notification filed by Medi-spec with the FDA for Laminaria Japonica Cervical Dilator.
| Device ID | K833068 |
| 510k Number | K833068 |
| Device Name: | LAMINARIA JAPONICA CERVICAL DILATOR |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | MEDI-SPEC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-08 |
| Decision Date | 1984-02-04 |