The following data is part of a premarket notification filed by Mednet Services, Inc. with the FDA for Medstar 150.
Device ID | K013081 |
510k Number | K013081 |
Device Name: | MEDSTAR 150 |
Classification | Stimulator, Muscle, Powered |
Applicant | MEDNET SERVICES, INC. 2855 ANTHONY LN. SOUTH, #B10 St. Anthony, MN 55418 |
Contact | David L Mathews |
Correspondent | David L Mathews MEDNET SERVICES, INC. 2855 ANTHONY LN. SOUTH, #B10 St. Anthony, MN 55418 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-14 |
Decision Date | 2001-11-20 |
Summary: | summary |