The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Ulcercare.
Device ID | K892867 |
510k Number | K892867 |
Device Name: | ULCERCARE |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
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 | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-19 |
Decision Date | 1989-07-20 |