510(k) K782067
- Device
- Dilator, Mizutani Laminaria Tent
- Applicant
- BRITISH MARKETING ENT., LTD.
- 510(k) number
- K782067
- Product code
- HDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-01-03
- Date received
- 1978-12-13
- Regulation
- 884.4260
- Classification name
- Dilator, Cervical, Hygroscopic-Laminaria
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1319639
- 1450908
- 3005483737
- 1422634
- 1424263
- 8030107
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HDY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040625 | ATAD ARD CATHETER | Atad Developments , Ltd. | 2005-01-18 |
| K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002-06-25 |
| K011512 | MMODIFICATION TO LAMINARIA | A & A Medical, Inc. | 2001-07-09 |
| K955072 | LAMINARIA | Cti Corp., Ltd. | 1996-05-22 |
| K892220 | LAMINARIA TENT | Berkeley Medevices | 1989-06-14 |
| K881295 | LAMINARIA CUREX | Harold W. Berger Co. | 1988-08-10 |
| K881312 | LAMINARIA | Busse Hospital Disposables, Inc. | 1988-05-23 |
| K880196 | LAMINARIA | Medgyn Products, Inc. | 1988-05-06 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | 1985-05-01 |
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Medi-Spec | 1984-02-04 |