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FDA 510(k), K132423, THE GYNOCULAR
FDA 510(k), K132423, THE GYNOCULAR
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510(K) Number: K132423
Device Name: THE GYNOCULAR
Manufacturer: GYNIUS AB
Device Classification Name: colposcope (and colpomicroscope)
Regulation Number: 884.1630
Classification Product Code: HEX
Date Received: 08/05/2013
Decision Date: 04/08/2014
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: THE GYNOCULAR
Manufacturer: GYNIUS AB
Device Classification Name: colposcope (and colpomicroscope)
Regulation Number: 884.1630
Classification Product Code: HEX
Date Received: 08/05/2013
Decision Date: 04/08/2014
Regulation Medical Specialty: Obstetrics/Gynecology
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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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