The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobst Extremity Pump(r) System 7500.
Device ID | K882683 |
510k Number | K882683 |
Device Name: | JOBST EXTREMITY PUMP(R) SYSTEM 7500 |
Classification | Sleeve, Limb, Compressible |
Applicant | JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
Contact | Wetzel, Cm |
Correspondent | Wetzel, Cm JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-30 |
Decision Date | 1988-09-20 |