510(k) K060908
- Device
- SONOHYSTEROGRAPHY BIOPSY DEVICE
- Applicant
- COOK UROLOGICAL, INC.
- 510(k) number
- K060908
- Product code
- PGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-29
- Date received
- 2006-04-03
- Regulation
- 884.4530
- Classification name
- Cannula, Injector, Uterine, Endometrial Biopsy
- 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
- CINDY RUMPLE
- Address
- 1100 W. Morgan St. Spencer IN US 47460 47460
FDA Registration Numbers#
- 3017262662
- 3008573567
- 1825146
- 1820334
Source Documents#
Other 510(k) Records For Product Code PGK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133144 | SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE | Crossbay Medical, Inc. | 2014-03-19 |
Legacy Summary#
summary
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