MLC FIT

Accelerator, Linear, Medical

IMPAC MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Mlc Fit.

Pre-market Notification Details

Device IDK962335
510k NumberK962335
Device Name:MLC FIT
ClassificationAccelerator, Linear, Medical
Applicant IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View,  CA  94041 -1203
ContactJoseph K Jachinowski
CorrespondentJoseph K Jachinowski
IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View,  CA  94041 -1203
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-17
Decision Date1997-02-06
Summary:summary

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