DECOMAT 228

Cleaners, Medical Devices

GETINGE INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Getinge International, Inc. with the FDA for Decomat 228.

Pre-market Notification Details

Device IDK920406
510k NumberK920406
Device Name:DECOMAT 228
ClassificationCleaners, Medical Devices
Applicant GETINGE INTERNATIONAL, INC. 1100 TOWBIN AVE. Lakewood,  NJ  08701
ContactPaul Rodriguez
CorrespondentPaul Rodriguez
GETINGE INTERNATIONAL, INC. 1100 TOWBIN AVE. Lakewood,  NJ  08701
Product CodeMDZ  
CFR Regulation Number880.6992 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-31
Decision Date1994-04-05

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