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FDA 510(k), K190918, SwabTip Male Disinfectant Cap
FDA 510(k), K190918, SwabTip Male Disinfectant Cap
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510(K) Number: K190918
Device Name: SwabTip Male Disinfectant Cap
Manufacturer: Nichelle Cato
Device Classification Name: Cap, Device Disinfectant
Regulation Number: QBP
Classification Product Code: KXA
Date Received: 04/09/2019
Decision Date: 03/06/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SwabTip Male Disinfectant Cap
Manufacturer: Nichelle Cato
Device Classification Name: Cap, Device Disinfectant
Regulation Number: QBP
Classification Product Code: KXA
Date Received: 04/09/2019
Decision Date: 03/06/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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