510(k) K032910

CARRIAZO PENDULAR by Schwind Eye-Tech-Solutions GmbH & Co. KG — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2004
Date Received
September 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type