STRYKER T6 HOODS AND TOGAS

About This 510(k) Submission

K063005 is an FDA 510(k) clearance for the STRYKER T6 HOODS AND TOGAS, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 23, 2007, 172 days after receiving the submission on October 2, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.