LELO RESPECT HEX Natural Rubber Latex Condom— 510(k) K162511

Name: FDA 510(k) clearance K162511
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Substantially Equivalent

Lelo, Inc.

FDA 510(k) clearance K162511 for LELO RESPECT HEX Natural Rubber Latex Condom, Substantially Equivalent on 2017-01-13. Applicant: Lelo, Inc.. Device class: 2.

Clearance details

Applicant: Lelo, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-08
Decision date: 2017-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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