The following data is part of a premarket notification filed by Harold W. Berger Co. with the FDA for Laminaria Curex.
| Device ID | K881295 |
| 510k Number | K881295 |
| Device Name: | LAMINARIA CUREX |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | HAROLD W. BERGER CO. P.O. BOX 767 Murrieta, CA 92362 |
| Contact | Harold W Berger |
| Correspondent | Harold W Berger HAROLD W. BERGER CO. P.O. BOX 767 Murrieta, CA 92362 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-08-10 |