510(k) Report

Devices descending from K993148

2 later devices reach Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040485Maxair Surgical Helmet SystemBio-Medical Devices, Inc.200401
+1K022162Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover…Stryker Instruments20020—