MAC LEE ENEMAD— 510(k) K791863

Clearance details

Applicant

Mac Lee Medical Products

Product code

Code FCE

Device class

Class 1

Regulation

21 CFR 876.5210

Advisory panel

Gastroenterology, Urology

Date received

1979-09-24

Decision date

1979-10-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K913620 — ENEMA KIT1991-11-01
• K904534 — ENEMA BULB1990-12-21

• K872953 — DISPOSABLE I.V. ADMINISTRATION SET1988-01-06
• K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF1987-11-17
• K870995 — SCALP VEIN SET1987-07-31
• K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC1986-12-29
• K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC1986-12-29

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 →