SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
FDA 510(k) clearance K201936 · decided 2021-05-06
Clearance details
- K-number
- K201936
- Device name
- SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
- Applicant
- Gilero, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-07-13
- Decision date
- 2021-05-06
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Morrisville, NC, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.