ENEMA KIT 'STRAIGHT' DESIGN— 510(k) K900848

Name: FDA 510(k) clearance K900848
Creator: U.S. Food and Drug Administration
Published: 1990-04-13

Substantially Equivalent

Custom Medical Products, Ltd.

FDA 510(k) clearance K900848 for ENEMA KIT 'STRAIGHT' DESIGN, Substantially Equivalent on 1990-04-13. Applicant: Custom Medical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Custom Medical Products, Ltd.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-22
Decision date: 1990-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maineville, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Custom Medical Products, Ltd.

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K931417 — STERILE EQUIPMENT COVERS1995-07-06
K931456 — SURGICAL DRAPE AND GOWN TRAY1994-07-08
K930815 — ABDOMINAL / THORACIC PATIENT DRAPE1994-05-05
K931418 — SURGICAL DRAPE1994-05-05
K931455 — HEAD SHEET1994-05-05

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.