ENEMA, PHOSPHATE— 510(k) K780613

Name: FDA 510(k) clearance K780613
Creator: U.S. Food and Drug Administration
Published: 1978-06-02

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K780613 for ENEMA, PHOSPHATE, Substantially Equivalent on 1978-06-02. Applicant: Abco Dealers, Inc.. Device class: 1.

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1978-04-10
Decision date: 1978-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Abco Dealers, Inc.

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K905025 — DIGITAL THERMOMETER KITS1991-02-07
K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)1988-07-12
K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS1988-04-21
K880894 — ALLERGIST SYRINGES1988-03-31
K872875 — STRETCH GAUZE BANDAGES1987-09-04

Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

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.