The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Enemad.
Device ID | K791863 |
510k Number | K791863 |
Device Name: | MAC LEE ENEMAD |
Classification | Enema Kit |
Applicant | MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FCE |
CFR Regulation Number | 876.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-24 |
Decision Date | 1979-10-02 |