510(k) K894511

MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT by Intl. Ophthalmic Industries Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
July 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type