IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
FDA 510(k) clearance K070354 · decided 2007-10-05
Clearance details
- K-number
- K070354
- Device name
- IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
- Applicant
- International Medical Development, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-06
- Decision date
- 2007-10-05
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Huntsville, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.