MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
FDA 510(k) clearance K951312 · decided 1995-05-03
Clearance details
- K-number
- K951312
- Device name
- MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-23
- Decision date
- 1995-05-03
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.