The following data is part of a premarket notification filed by Berkeley Medevices with the FDA for Laminaria Tent.
| Device ID | K892220 |
| 510k Number | K892220 |
| Device Name: | LAMINARIA TENT |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | BERKELEY MEDEVICES 907 CAMELIA ST. Berkeley, CA 94710 |
| Contact | Julie Caselli |
| Correspondent | Julie Caselli BERKELEY MEDEVICES 907 CAMELIA ST. Berkeley, CA 94710 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-06-14 |