SAFETY NEEDLE
FDA 510(k) clearance K051019 · decided 2005-07-25
Clearance details
- K-number
- K051019
- Device name
- SAFETY NEEDLE
- Applicant
- Sarstedt, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-22
- Decision date
- 2005-07-25
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newton, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.