510(k) K093508
- Device
- RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
- Applicant
- WOMANCARE GLOBAL
- 510(k) number
- K093508
- Product code
- HGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-04
- Date received
- 2009-11-12
- Regulation
- 884.5070
- Classification name
- Cannula, Suction, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Susanne Parks
- Address
- 300 Market St. Suite 134 Chapel Hill NC US 27516 27516
FDA Registration Numbers#
- 1450908
- 8044099
- 3011219572
- 3008007615
- 3014615028
Source Documents#
Other 510(k) Records For Product Code HGH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018-04-09 |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | 2017-01-13 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 |
| K935820 | KOLSTER METHODS | Kolster Methods | 1994-07-19 |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | 1984-05-09 |
Legacy Summary#
summary
FDA Review#
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