510(k) K960241

CPR GENERAL SURGERY TRAY by Custom Pack Reliability — Product Code LWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound, Sinus
Device Class
Class II
Regulation Number
892.1560
Review Panel
EN
Submission Type