TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
FDA 510(k) clearance K131531 · decided 2014-05-12
Clearance details
- K-number
- K131531
- Device name
- TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
- Applicant
- Anhui Tiankang Medical Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-28
- Decision date
- 2014-05-12
- Days to decision
- 349 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tianchang City, Anhui Province, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.