Cleared Special

K011755 - STRYKER T4 HYTREL (R) TOGAS
(FDA 510(k) Clearance)

K011755 · Stryker Corp. · General Hospital

Jun 2001

Decision

16d

Days

Class 1

Risk

K011755 is an FDA 510(k) clearance for the STRYKER T4 HYTREL (R) TOGAS. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on June 22, 2001, 16 days after receiving the submission on June 6, 2001.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K011755 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2001
Decision Date	June 22, 2001
Days to Decision	16 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Statement