510(k) DEN090011
- Device
- HEM-AVERT PERIANAL STABILIZER
- Applicant
- Plexus Biomedical, Inc.
- 510(k) number
- DEN090011
- Product code
- OOA
- Decision
- Unknown (DENG)
- Decision date
- 2011-01-13
- Date received
- 2009-08-18
- Regulation
- 884.5200
- Classification name
- Hemorrhoid Prevention Pressure Wedge
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID BLURTON
- Address
- 70 Clay St. Suite 2 Oakland TN US 38060 38060
FDA Registration Numbers#
- 3008466086
- 3005550381
Source Documents#
510(k) summary PDF not indicated by FDA