LONZA FORMULATION R-82

Disinfectant, Medical Devices

CALGON VESTAL DIV.

The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Lonza Formulation R-82.

Pre-market Notification Details

Device IDK932277
510k NumberK932277
Device Name:LONZA FORMULATION R-82
ClassificationDisinfectant, Medical Devices
Applicant CALGON VESTAL DIV. C/O LONZA, INC. 17-17 ROUTE 208 Fair Lawn,  NJ  07410
ContactJoseph R Robinson
CorrespondentJoseph R Robinson
CALGON VESTAL DIV. C/O LONZA, INC. 17-17 ROUTE 208 Fair Lawn,  NJ  07410
Product CodeLRJ  
CFR Regulation Number880.6890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-12
Decision Date1994-05-12

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