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 |