SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5

Counter, Differential Cell

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Software Modification For Miles H*1 S/w Ver. 1.5.

Pre-market Notification Details

Device IDK920949
510k NumberK920949
Device Name:SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
ClassificationCounter, Differential Cell
Applicant HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactThomas C Brewster
CorrespondentThomas C Brewster
HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-02
Decision Date1992-05-15

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