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FDA 510(k), K183384, JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
FDA 510(k), K183384, JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
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$49.00 USD
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510(K) Number: K183384
Device Name: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
Manufacturer: Stephanie Morris
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: KXA
Date Received: 12/06/2018
Decision Date: 03/04/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
Manufacturer: Stephanie Morris
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: KXA
Date Received: 12/06/2018
Decision Date: 03/04/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- 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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