The following data is part of a premarket notification filed by Mednet, Inc. with the FDA for Caster Car.
Device ID | K862892 |
510k Number | K862892 |
Device Name: | CASTER CAR |
Classification | Wheelchair, Mechanical |
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 | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-22 |
Decision Date | 1986-08-14 |