510(k) K823516

ESA CAMERA by Concept, Inc. — Product Code FWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
November 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Cine, Surgical, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type