510(k) K133144
- Device
- SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
- Applicant
- CrossBay Medical, Inc.
- 510(k) number
- K133144
- Product code
- PGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-19
- Date received
- 2013-10-17
- 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 DOMECUS
- Address
- 17141 Murphy Ave., Suite 5c Irvine CA US 94901 94901
FDA Registration Numbers#
- 3017262662
- 3008573567
- 1825146
- 1820334
Source Documents#
Other 510(k) Records For Product Code PGK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE | Cook Urological, Inc. | 2006-06-29 |
Legacy Summary#
summary
FDA Review#
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