ENEMA SET— 510(k) K771792

Name: FDA 510(k) clearance K771792
Creator: U.S. Food and Drug Administration
Published: 1977-10-20

Substantially Equivalent

Chase Mfg. Co.

FDA 510(k) clearance K771792 for ENEMA SET, Substantially Equivalent on 1977-10-20. Applicant: Chase Mfg. Co.. Device class: 1.

Clearance details

Applicant: Chase Mfg. Co.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1977-09-22
Decision date: 1977-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K974042 — AMSURE CLEANSING ENEMA SET1997-12-19
K931896 — PRO-FLO SYSTEM1993-08-26
K922398 — 4 SURE TM ENEMA BAG SET1993-06-17
K913620 — ENEMA KIT1991-11-01
K904534 — ENEMA BULB1990-12-21

More clearances from Chase Mfg. Co.

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K791513 — ADAMCO DUST COVER1979-10-11
K790993 — INSTANT HOT & COLD PACKS1979-09-07
K790644 — SUBMAX1979-04-26
K780033 — MATTRESSES, CONDUCTIVE & COVERS1978-02-21
K771791 — NEEDLE COUNTING1977-10-04

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.