510(k) K011755

STRYKER T4 HYTREL (R) TOGAS by Stryker Corp. — Product Code LYU

K011755 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER T4 HYTREL (R) TOGAS". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Stryker Corp. has at least 10 other 510(k) clearances on record.