SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
FDA 510(k) clearance K012453 · decided 2001-10-22
Clearance details
- K-number
- K012453
- Device name
- SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
- Applicant
- Sodemsystems
- Decision
- Substantially Equivalent
- Date received
- 2001-08-01
- Decision date
- 2001-10-22
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Geneva, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.