ENDOSCOPIC CAMERA TV W/AUDIO

Camera, Surgical And Accessories

KAMIYA TSUSAN KAISHA, LTD.

The following data is part of a premarket notification filed by Kamiya Tsusan Kaisha, Ltd. with the FDA for Endoscopic Camera Tv W/audio.

Pre-market Notification Details

Device IDK832342
510k NumberK832342
Device Name:ENDOSCOPIC CAMERA TV W/AUDIO
ClassificationCamera, Surgical And Accessories
Applicant KAMIYA TSUSAN KAISHA, LTD. CPO BOX 1590 TOKYO 100-91 JAPAN , 
Product CodeKQM  
CFR Regulation Number878.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-12
Decision Date1983-09-12

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