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FDA 510(k), K141913, PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
FDA 510(k), K141913, PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
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510(K) Number: K141913
Device Name: PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
Manufacturer: CANDACE F CEDERMAN
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: KXA
Date Received: 07/15/2014
Decision Date: 04/06/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
Manufacturer: CANDACE F CEDERMAN
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: KXA
Date Received: 07/15/2014
Decision Date: 04/06/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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