The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobst Athrombic Pump(r) System 2000.
Device ID | K895732 |
510k Number | K895732 |
Device Name: | JOBST ATHROMBIC PUMP(R) SYSTEM 2000 |
Classification | Sleeve, Limb, Compressible |
Applicant | JOBST INSTITUTE, INC. P.O. BOX 653 Toledo, OH 43697 -0653 |
Contact | Wetzel, Cm |
Correspondent | Wetzel, Cm JOBST INSTITUTE, INC. P.O. BOX 653 Toledo, OH 43697 -0653 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-26 |
Decision Date | 1990-01-26 |