SPINAL NEEDLES
FDA 510(k) clearance K961151 · decided 1997-03-19
Clearance details
- K-number
- K961151
- Device name
- SPINAL NEEDLES
- Applicant
- Hakko Shoji Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-22
- Decision date
- 1997-03-19
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.