The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobst Athrombic Pump - System 2500.
Device ID | K934639 |
510k Number | K934639 |
Device Name: | JOBST ATHROMBIC PUMP - SYSTEM 2500 |
Classification | Sleeve, Limb, Compressible |
Applicant | JOBST INSTITUTE, INC. P.O. BOX 471048 Charlotte, NC 28247 -1048 |
Contact | Kenneth M Bolam |
Correspondent | Kenneth M Bolam JOBST INSTITUTE, INC. P.O. BOX 471048 Charlotte, NC 28247 -1048 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-29 |
Decision Date | 1994-02-09 |