510(k) K063005

STRYKER T6 HOODS AND TOGAS by Stryker Instruments — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2007
Date Received
October 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type