TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
FDA 510(k) clearance K190539 · decided 2019-10-22
Clearance details
- K-number
- K190539
- Device name
- TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
- Applicant
- Monumedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-03-04
- Decision date
- 2019-10-22
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- FMG
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Roseville, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.