MAC LEE ENEMAD

Enema Kit

MAC LEE MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Enemad.

Pre-market Notification Details

Device IDK791863
510k NumberK791863
Device Name:MAC LEE ENEMAD
ClassificationEnema Kit
Applicant MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFCE  
CFR Regulation Number876.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-24
Decision Date1979-10-02

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