K881312 is an FDA 510(k) clearance for the LAMINARIA. This device is classified as a Dilator, Cervical, Hygroscopic-laminaria (Class II - Special Controls, product code HDY).
Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 23, 1988, 56 days after receiving the submission on March 28, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4260.
| 510(k) Number | K881312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1988 |
| Decision Date | May 23, 1988 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDY — Dilator, Cervical, Hygroscopic-laminaria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4260 |