Lelo Hex Natural Rubber Latex Condom— 510(k) K160644

Substantially Equivalent

Lelo, Inc.

FDA 510(k) clearance K160644 for Lelo Hex Natural Rubber Latex Condom, Substantially Equivalent on 2016-06-30. Applicant: Lelo, Inc..

Clearance details

Applicant: Lelo, Inc.
Product code: Code HIS
Advisory panel: Obstetrics/Gynecology
Date received: 2016-03-07
Decision date: 2016-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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