The following data is part of a premarket notification filed by Medgyn Products, Inc. with the FDA for Laminaria.
| Device ID | K880196 |
| 510k Number | K880196 |
| Device Name: | LAMINARIA |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | MEDGYN PRODUCTS, INC. 2808 A. CENTER CIRCLE Downers Grove, IL 60515 |
| Contact | Lakshman Agadi |
| Correspondent | Lakshman Agadi MEDGYN PRODUCTS, INC. 2808 A. CENTER CIRCLE Downers Grove, IL 60515 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-05-06 |