PENCIL POINT NEEDLE
FDA 510(k) clearance K041843 · decided 2004-08-24
Clearance details
- K-number
- K041843
- Device name
- PENCIL POINT NEEDLE
- Applicant
- Epimed International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-08
- Decision date
- 2004-08-24
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Johnstown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.