FDA 510(k), K160644, Lelo Hex Natural Rubber Latex Condom

FDA 510(k), K160644, Lelo Hex Natural Rubber Latex Condom

Regular price $49.00 USD
Regular price Sale price $49.00 USD
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510(K) Number: K160644
Device Name: Lelo Hex Natural Rubber Latex Condom
Manufacturer: LELO Inc.
Device Classification Name: condom
Regulation Number: 884.5300
Classification Product Code: HIS
Date Received: 03/07/2016
Decision Date: 06/30/2016
Regulation Medical Specialty: Obstetrics/Gynecology
  • 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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