510(k) K923670

BYRNE EXPULSIVE LENS by Ocular Instruments, Inc. — Product Code HJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1992
Date Received
July 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Fundus, Hruby, Diagnostic
Device Class
Class I
Regulation Number
886.1395
Review Panel
OP
Submission Type