510(k) K913626

SOFTRANS INJECTOR by Staar Surgical Co. — Product Code HQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
August 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraocular Lens
Device Class
Class III
Regulation Number
886.3600
Review Panel
OP
Submission Type