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FDA 510(k), K940046, NON-LUBRICATED CONDOM
FDA 510(k), K940046, NON-LUBRICATED CONDOM
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510(K) Number: K940046
Device Name: NON-LUBRICATED CONDOM
Manufacturer: ANSELL, INC.
Device Classification Name: condom
Regulation Number: 884.5300
Classification Product Code: HIS
Date Received: 01/05/1994
Decision Date: 01/30/1995
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: NON-LUBRICATED CONDOM
Manufacturer: ANSELL, INC.
Device Classification Name: condom
Regulation Number: 884.5300
Classification Product Code: HIS
Date Received: 01/05/1994
Decision Date: 01/30/1995
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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