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510(k) K082043

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2008
Date Received
July 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Schwind Eye-Tech-Solutions GmbH & Co. KG

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