AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
FDA 510(k) clearance K141640 · decided 2014-11-19
Clearance details
- K-number
- K141640
- Device name
- AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2014-06-19
- Decision date
- 2014-11-19
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lafayette, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.