Zuno Smart Sterilization Container
FDA 510(k) clearance DEN210004 · decided 2022-06-17
Clearance details
- K-number
- DEN210004
- Device name
- Zuno Smart Sterilization Container
- Applicant
- Zuno Medical, Inc.
- Decision
- Unknown
- Date received
- 2021-02-16
- Decision date
- 2022-06-17
- Days to decision
- 486 days
- Clearance type
- Direct
- Product code
- QJT
- Device class
- 2
- Regulation number
- 880.6855
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.