510(k) Report

Devices descending from K090259

3 later devices reach Okamoto Ultra Thin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192669Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc.20202—
+2K252622Male Latex Condom HAOkamoto USA, Inc.20260—
+2K213921Microthin Natural Rubber Latex CondomSuretex Limited20220—