The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Ulcercare.
| Device ID | K912232 |
| 510k Number | K912232 |
| Device Name: | ULCERCARE |
| Classification | Wound Dressing Kit |
| 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 | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-08-14 |