MYSAFETY SYRINGE
FDA 510(k) clearance K111734 · decided 2011-09-06
Clearance details
- K-number
- K111734
- Device name
- MYSAFETY SYRINGE
- Applicant
- Medicalchain Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-21
- Decision date
- 2011-09-06
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Thousand Oaks, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.