510(k) K820254

GOLD FOIL ERG ELECTRODES by Cadwell Laboratories, Inc. — Product Code HLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
February 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type