510(k) K904969

HOOD, OPERATING, SURGICAL by Chicago Assoc. For Retarded Citizens — Product Code FXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1990
Date Received
November 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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