INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
FDA 510(k) clearance K083851 · decided 2009-05-15
Clearance details
- K-number
- K083851
- Device name
- INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
- Applicant
- Inviro Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-24
- Decision date
- 2009-05-15
- Days to decision
- 142 days
- Clearance type
- Special
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lawrenceville, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.