510(k) DEN130040
- Device
- IOGYN SYSTEM
- Applicant
- Iogyn, Inc.
- 510(k) number
- DEN130040
- Product code
- PGT
- Decision
- Unknown (DENG)
- Decision date
- 2014-03-28
- Date received
- 2013-08-30
- Regulation
- 884.1710
- Classification name
- Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARY EDWARDS
- Address
- 20195 Stevens Creek Blvd. Suite 120 Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3009327445
- 3011011193
- 3043236281
- 2183613
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA