FDA.reportPublic FDA data

510(k) K033182

Device
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
Applicant
Surgin Surgical Instrumentation, Inc.
510(k) number
K033182
Product code
HNO
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-30
Date received
2003-10-01
Regulation
886.4370
Classification name
Keratome, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
DON HAAR
Address
14762 Bentley Cir. Tustin CA US 92680 92680

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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