The following data is part of a premarket notification filed by Mednet, Inc. with the FDA for Kooychair (pediatric).
Device ID | K862886 |
510k Number | K862886 |
Device Name: | KOOYCHAIR (PEDIATRIC) |
Classification | Chair, With Casters |
Applicant | MEDNET, INC. 4950 WEST DICKMAN RD. Battle Creek, MI 49016 |
Contact | Van Dillen |
Correspondent | Van Dillen MEDNET, INC. 4950 WEST DICKMAN RD. Battle Creek, MI 49016 |
Product Code | INM |
CFR Regulation Number | 890.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-22 |
Decision Date | 1986-08-13 |