ACDS

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

ISOPURE CORP.

The following data is part of a premarket notification filed by Isopure Corp. with the FDA for Acds.

Pre-market Notification Details

Device IDK120005
510k NumberK120005
Device Name:ACDS
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville,  KY  40067 -6548
ContactKevin Gillespie
CorrespondentKevin Gillespie
ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville,  KY  40067 -6548
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852456007092 K120005 000

Trademark Results [ACDS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACDS
ACDS
88672703 not registered Live/Pending
American Contact Dermatitis Society
2019-10-29
ACDS
ACDS
87596983 5457901 Live/Registered
ACDS HONG KONG LIMITED
2017-09-05
ACDS
ACDS
85273142 4242744 Dead/Cancelled
4 S Technologies, LLC
2011-03-22
ACDS
ACDS
85273136 4242743 Dead/Cancelled
4 S Technologies, LLC
2011-03-22
ACDS
ACDS
77940033 3932511 Live/Registered
Medline Industries, Inc.
2010-02-19
ACDS
ACDS
77359928 3487916 Dead/Cancelled
Atlas Copco Drilling Solutions, LLC
2007-12-27
ACDS
ACDS
76014184 not registered Dead/Abandoned
WG Apparel, Inc.
2000-03-31

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