GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS— 510(k) K901472

Name: FDA 510(k) clearance K901472
Creator: U.S. Food and Drug Administration
Published: 1990-07-27

Substantially Equivalent

Granite Chemical Co., Inc.

FDA 510(k) clearance K901472 for GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS, Substantially Equivalent on 1990-07-27. Applicant: Granite Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Granite Chemical Co., Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-28
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Airy, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Granite Chemical Co., Inc.

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K901471 — GC-1000 THROUGH GC-3005 ACID CONCENTRATE1990-07-27
K901473 — GC-01 THROUGH GC-99 ACETATE CONCENTRATE1990-07-27

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.