GC-1000 THROUGH GC-3005 ACID CONCENTRATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

GRANITE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Granite Chemical Co., Inc. with the FDA for Gc-1000 Through Gc-3005 Acid Concentrate.

Pre-market Notification Details

• Device ID: K901471
• 510k Number: K901471
• Device Name: GC-1000 THROUGH GC-3005 ACID CONCENTRATE
• Classification: Dialysate Concentrate For Hemodialysis (liquid Or Powder)
• Applicant: GRANITE CHEMICAL CO., INC. P.O. BOX 1504 Mount Airy, NC 27030
• Contact: J Griswold
• Correspondent: J Griswold; GRANITE CHEMICAL CO., INC. P.O. BOX 1504 Mount Airy, NC 27030
• Product Code: KPO
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-03-28
• Decision Date: 1990-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10817411021039	K901471	000
00817411021384	K901471	000
10817411021374	K901471	000
10817411022524	K901471	000
10817411022487	K901471	000
10817411022449	K901471	000
10817411022425	K901471	000
10817411022050	K901471	000
10817411022036	K901471	000
10817411021992	K901471	000
10817411021978	K901471	000
10817411021893	K901471	000
10817411021879	K901471	000
10817411021855	K901471	000
10817411021732	K901471	000
10817411022012	K901471	000
10817411021954	K901471	000
10817411021404	K901471	000
00817411021414	K901471	000
10817411021015	K901471	000
10817411020490	K901471	000
10817411020438	K901471	000
10817411020339	K901471	000
10817411020162	K901471	000
00817411020110	K901471	000
00817411020103	K901471	000
10817411020087	K901471	000
00817411020073	K901471	000
10817411020063	K901471	000
00817411020059	K901471	000
00817411020042	K901471	000
00817411021476	K901471	000
10817411021466	K901471	000
00817411021445	K901471	000
10817411021435	K901471	000
10817411021534	K901471	000