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 ID | K120005 |
| 510k Number | K120005 |
| Device Name: | ACDS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville, KY 40067 -6548 |
| Contact | Kevin Gillespie |
| Correspondent | Kevin Gillespie ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville, KY 40067 -6548 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-03-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852456007092 | K120005 | 000 |
Trademark Results [ACDS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACDS 88672703 not registered Live/Pending |
American Contact Dermatitis Society 2019-10-29 |
 ACDS 87596983 5457901 Live/Registered |
ACDS HONG KONG LIMITED 2017-09-05 |
 ACDS 85273142 4242744 Dead/Cancelled |
4 S Technologies, LLC 2011-03-22 |
 ACDS 85273136 4242743 Dead/Cancelled |
4 S Technologies, LLC 2011-03-22 |
 ACDS 77940033 3932511 Live/Registered |
Medline Industries, Inc. 2010-02-19 |
 ACDS 77359928 3487916 Dead/Cancelled |
Atlas Copco Drilling Solutions, LLC 2007-12-27 |
 ACDS 76014184 not registered Dead/Abandoned |
WG Apparel, Inc. 2000-03-31 |
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