SURGICAL VIDEO CAMERA AND ACCESSORIES

Camera, Television, Endoscopic, Without Audio

MEDICAL DYNAMICS, INC.

The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Surgical Video Camera And Accessories.

Pre-market Notification Details

Device IDK934682
510k NumberK934682
Device Name:SURGICAL VIDEO CAMERA AND ACCESSORIES
ClassificationCamera, Television, Endoscopic, Without Audio
Applicant MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood,  CO  80112
ContactJo Brehm
CorrespondentJo Brehm
MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood,  CO  80112
Product CodeFWF  
CFR Regulation Number878.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-30
Decision Date1994-02-15

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