FDA 510(k), K200242, StaClear Syringe
FDA 510(k), K200242, StaClear Syringe
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510(K) Number: K200242
Device Name: StaClear Syringe
Manufacturer: TriboFilm Research, Inc.
Device Classification Name: Ophthalmic Syringe
Regulation Number: 880.5860
Classification Product Code: QLY
Date Received: 01/31/2020
Decision Date: 07/27/2020
Regulation Medical Specialty: General Hospital
Device Name: StaClear Syringe
Manufacturer: TriboFilm Research, Inc.
Device Classification Name: Ophthalmic Syringe
Regulation Number: 880.5860
Classification Product Code: QLY
Date Received: 01/31/2020
Decision Date: 07/27/2020
Regulation Medical Specialty: General Hospital
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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