REPROCESSED ATHROSCOPICS BURS
FDA 510(k) clearance K012605 · decided 2001-11-07
Clearance details
- K-number
- K012605
- Device name
- REPROCESSED ATHROSCOPICS BURS
- Applicant
- Alliance Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2001-11-07
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alliance Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.