The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Rollchair, Ortho Bucket Seat.
Device ID | K790560 |
510k Number | K790560 |
Device Name: | ROLLCHAIR, ORTHO BUCKET SEAT |
Classification | Chair, With Casters |
Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | INM |
CFR Regulation Number | 890.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-19 |
Decision Date | 1979-04-10 |