STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
FDA 510(k) clearance K090929 · decided 2009-06-12
Clearance details
- K-number
- K090929
- Device name
- STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
- Applicant
- Shanghai Double Dove Industrial Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-02
- Decision date
- 2009-06-12
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.