The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Baby Walker W/toy Chest.
Device ID | K812474 |
510k Number | K812474 |
Device Name: | BABY WALKER W/TOY CHEST |
Classification | Exerciser, Non-measuring |
Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ION |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-31 |
Decision Date | 1981-09-14 |