DANTEC DISPOSABLE CONCENTRIC NEEDLE
FDA 510(k) clearance K931966 · decided 1994-03-30
Clearance details
- K-number
- K931966
- Device name
- DANTEC DISPOSABLE CONCENTRIC NEEDLE
- Applicant
- Dantec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-21
- Decision date
- 1994-03-30
- Days to decision
- 343 days
- Clearance type
- Traditional
- Product code
- IKT
- Device class
- 2
- Regulation number
- 890.1385
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.