The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Sitz Bath.
Device ID | K841711 |
510k Number | K841711 |
Device Name: | MAC LEE SITZ BATH |
Classification | Bath, Sitz, Nonpowered |
Applicant | MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTC |
CFR Regulation Number | 890.5125 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-24 |
Decision Date | 1984-05-07 |