The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Ultimate.
Device ID | K920444 |
510k Number | K920444 |
Device Name: | ULTIMATE |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
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 | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-03 |
Decision Date | 1992-04-20 |
Summary: | summary |