FDA.reportPublic FDA data

510(k) K082043

Device
CARRIAZO-PENDULAR MICROKERATOME
Applicant
Schwind Eye-Tech-Solutions GmbH & Co. KG
510(k) number
K082043
Product code
HNO
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-01
Date received
2008-07-18
Regulation
886.4370
Classification name
Keratome, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
ROLF SCHWIND
Address
Mainparkstrasse 6-10 Kleinostheim DE 63801 63801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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