DISPOSABLE CHIBA-TYPE NEEDLE
FDA 510(k) clearance K813368 · decided 1982-01-05
Clearance details
- K-number
- K813368
- Device name
- DISPOSABLE CHIBA-TYPE NEEDLE
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-30
- Decision date
- 1982-01-05
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GAA
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/ recall (Z-1063-2011) | Inrad, Inc | 2011-02-08 |