INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
FDA 510(k) clearance K070203 · decided 2007-04-23
Clearance details
- K-number
- K070203
- Device name
- INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
- Applicant
- Inviro Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-22
- Decision date
- 2007-04-23
- Days to decision
- 91 days
- Clearance type
- Special
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Duluth, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.