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FDA 510(k), K171213, One Touch Condom with Benzocaine
FDA 510(k), K171213, One Touch Condom with Benzocaine
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510(K) Number: K171213
Device Name: One Touch Condom with Benzocaine
Manufacturer: Pisut Chanwatarungkull (Pete)
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 04/25/2017
Decision Date: 01/12/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: One Touch Condom with Benzocaine
Manufacturer: Pisut Chanwatarungkull (Pete)
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 04/25/2017
Decision Date: 01/12/2018
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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