HEM-AVERT PERIANAL STABILIZER
FDA 510(k) clearance DEN090011 · decided 2011-01-13
Clearance details
- K-number
- DEN090011
- Device name
- HEM-AVERT PERIANAL STABILIZER
- Applicant
- Plexus Biomedical, Inc.
- Decision
- Unknown
- Date received
- 2009-08-18
- Decision date
- 2011-01-13
- Days to decision
- 513 days
- Clearance type
- Post-NSE
- Product code
- OOA
- Device class
- 2
- Regulation number
- 884.5200
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oakland, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.