The following data is part of a premarket notification filed by Mednet, Inc. with the FDA for Perambulator (stroller).
Device ID | K862888 |
510k Number | K862888 |
Device Name: | PERAMBULATOR (STROLLER) |
Classification | Stroller, Adaptive |
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 | LBE |
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 | 1986-08-13 |