510(k) K951984

WHITE KNIGHT SURGEON'S VEST by White Knight Healthcare — Product Code FYA

K951984 is an FDA 510(k) premarket notification submitted by White Knight Healthcare for the device "WHITE KNIGHT SURGEON'S VEST". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. White Knight Healthcare has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
April 27, 1995
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