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FDA 510(k), K152531, InstaClear Lens Cleaner
FDA 510(k), K152531, InstaClear Lens Cleaner
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510(K) Number: K152531
Device Name: InstaClear Lens Cleaner
Manufacturer: GYRUS ACMI, INC.
Device Classification Name: nasopharyngoscope (flexible or rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 09/03/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: Ear Nose & Throat
Device Name: InstaClear Lens Cleaner
Manufacturer: GYRUS ACMI, INC.
Device Classification Name: nasopharyngoscope (flexible or rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 09/03/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: Ear Nose & Throat
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- 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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