PREASSEMBLED SURGICAL WASH SET
FDA 510(k) clearance K103202 · decided 2010-11-23
Clearance details
- K-number
- K103202
- Device name
- PREASSEMBLED SURGICAL WASH SET
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-01
- Decision date
- 2010-11-23
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.