Submission Details
| 510(k) Number | K955072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 1995 |
| Decision Date | May 22, 1996 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
Cleared
Traditional
LAMINARIA
May 1996
Decision
198d
Days
Class 2
Risk
About This 510(k) Submission
K955072 is an FDA 510(k) clearance for the LAMINARIA, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by Cti Corp., Ltd. (Vacaville, US). The FDA issued a Cleared decision on May 22, 1996, 198 days after receiving the submission on November 6, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.
Device Classification
| Product Code | HDY — Dilator, Cervical, Hygroscopic-laminaria |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
Similar Devices — HDY Dilator, Cervical, Hygroscopic-laminaria
All 10
K040625 · Atad Developments , Ltd.
· Jan 2005
K021012 · Quality Medical Solusions, LLC
· Jun 2002
K011512 · A & A Medical, Inc.
· Jul 2001
K892220 · Berkeley Medevices
· Jun 1989
K881295 · Harold W. Berger Co.
· Aug 1988
K881312 · Busse Hospital Disposables, Inc.
· May 1988