The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobst-custom.
Device ID | K925154 |
510k Number | K925154 |
Device Name: | JOBST-CUSTOM |
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 | 1992-10-13 |
Decision Date | 1994-04-04 |