The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobst Extremity Pump System 7500.
Device ID | K921562 |
510k Number | K921562 |
Device Name: | JOBST EXTREMITY PUMP SYSTEM 7500 |
Classification | Sleeve, Limb, Compressible |
Applicant | JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
Contact | Angelo R Pereira |
Correspondent | Angelo R Pereira 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 | 1992-04-01 |
Decision Date | 1992-06-22 |