Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
FDA 510(k) clearance K161950 · decided 2017-05-11
Clearance details
- K-number
- K161950
- Device name
- Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-15
- Decision date
- 2017-05-11
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.