510(k) K161106
- Device
- PANPAC DISPOSABLE VACUUM CURETTES
- Applicant
- PANPAC MEDICAL CORPORATION
- 510(k) number
- K161106
- Product code
- HGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-13
- Date received
- 2016-04-19
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- YEN-MING PAN
- Address
- 6f-1,2, # 202, Sec.3, Ta-Tong Rd. Shi-Chih Dist. TW 22103 22103
FDA Registration Numbers#
- 8044099
- 3008007615
- 3011219572
- 3014615028
- 1450908
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Womancare Global | 2010-03-04 |
| K935820 | KOLSTER METHODS | Kolster Methods | 1994-07-19 |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | 1984-05-09 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases