Promisemed Sharps container
FDA 510(k) clearance K211890 · decided 2021-11-17
Clearance details
- K-number
- K211890
- Device name
- Promisemed Sharps container
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-21
- Decision date
- 2021-11-17
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hangzhou City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.