The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Plastic Shower Guard.
Device ID | K791646 |
510k Number | K791646 |
Device Name: | PLASTIC SHOWER GUARD |
Classification | Cover, Cast |
Applicant | B & F MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIA |
CFR Regulation Number | 880.6185 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-24 |
Decision Date | 1979-10-01 |