ARTHROSCOPY PUMP, MODEL A107
FDA 510(k) clearance K030402 · decided 2003-04-17
Clearance details
- K-number
- K030402
- Device name
- ARTHROSCOPY PUMP, MODEL A107
- Applicant
- W.O.M. World of Medicine AG
- Decision
- Substantially Equivalent
- Date received
- 2003-02-06
- Decision date
- 2003-04-17
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.