REMEDY MODEL 2Z12

Purifier, Water, Ultraviolet, Medical

APOLLO CORP.

The following data is part of a premarket notification filed by Apollo Corp. with the FDA for Remedy Model 2z12.

Pre-market Notification Details

Device IDK012029
510k NumberK012029
Device Name:REMEDY MODEL 2Z12
ClassificationPurifier, Water, Ultraviolet, Medical
Applicant APOLLO CORP. 450 MAIN ST. Somerset,  WI  54025
ContactAdrian Sween
CorrespondentAdrian Sween
APOLLO CORP. 450 MAIN ST. Somerset,  WI  54025
Product CodeKMG  
CFR Regulation Number880.6710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-28
Decision Date2001-12-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.