OPM SLIT LAMP MODEL P-1 & MODEL P-3

Biomicroscope, Slit-lamp, Ac-powered

OPTEK MEDICO CO., LTD.

The following data is part of a premarket notification filed by Optek Medico Co., Ltd. with the FDA for Opm Slit Lamp Model P-1 & Model P-3.

Pre-market Notification Details

Device IDK863048
510k NumberK863048
Device Name:OPM SLIT LAMP MODEL P-1 & MODEL P-3
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU 1-19, 2 CHOME, KANDA-SURUGADAI Chiyoda-ku Tokyo Japan,  JP
ContactAtsushi Hirayama
CorrespondentAtsushi Hirayama
OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU 1-19, 2 CHOME, KANDA-SURUGADAI Chiyoda-ku Tokyo Japan,  JP
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-12
Decision Date1986-09-03

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