The following data is part of a premarket notification filed by Cti Corp., Ltd. with the FDA for Laminaria.
| Device ID | K955072 |
| 510k Number | K955072 |
| Device Name: | LAMINARIA |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | CTI CORP., LTD. 607 ELMIRA RD. Vacaville, CA 95687 |
| Contact | Oscar Pelaez Tan |
| Correspondent | Oscar Pelaez Tan CTI CORP., LTD. 607 ELMIRA RD. Vacaville, CA 95687 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-05-22 |