MODIFICATION TO TEMNO BIOPSY NEEDLES
FDA 510(k) clearance K024120 · decided 2003-01-15
Clearance details
- K-number
- K024120
- Device name
- MODIFICATION TO TEMNO BIOPSY NEEDLES
- Applicant
- Allegiance Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-16
- Decision date
- 2003-01-15
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.