510(k) K913239

GOLDLENS(TM) by Doran Instruments, Inc. — Product Code HLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1992
Date Received
July 22, 1991
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