The following data is part of a premarket notification filed by Orthion Corp. with the FDA for Lavatory Seat Heightener.
Device ID | K823155 |
510k Number | K823155 |
Device Name: | LAVATORY SEAT HEIGHTENER |
Classification | Adaptor, Hygiene |
Applicant | ORTHION CORP. 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 | 1982-10-20 |
Decision Date | 1982-11-05 |