SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500

Biomicroscope, Slit-lamp, Ac-powered

HUVITZ CO., LTD.

The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Slit Lamp, Models Hs-5000, Hs-5500 And Hs-7500.

Pre-market Notification Details

Device IDK093639
510k NumberK093639
Device Name:SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant HUVITZ CO., LTD. 136 W. ORION SUITE 3 Tempe,  AZ  85283
ContactMatew J Wess
CorrespondentMarc M Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-11-24
Decision Date2009-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019600060 K093639 000
08800019600053 K093639 000
08800019600015 K093639 000
08800019600077 K093639 000
08800019600039 K093639 000
08800019600022 K093639 000

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