Nam Illumination Probe With Chopper

Endoilluminator

Oculight Ltd.

The following data is part of a premarket notification filed by Oculight Ltd. with the FDA for Nam Illumination Probe With Chopper.

Pre-market Notification Details

Device IDK202670
510k NumberK202670
Device Name:Nam Illumination Probe With Chopper
ClassificationEndoilluminator
Applicant Oculight Ltd. Seongnamdaelo 1342, B111 Seongnam-si,  KR 13120
ContactJinman Kim
CorrespondentRobert Packard
Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury,  VT  05738
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2021-08-20

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