The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Toilet Seat Raised.
Device ID | K830425 |
510k Number | K830425 |
Device Name: | TOILET SEAT RAISED |
Classification | Adaptor, Hygiene |
Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILS |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-09 |
Decision Date | 1983-05-09 |