The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Cutinova Foam.
| Device ID | K922681 |
| 510k Number | K922681 |
| Device Name: | CUTINOVA FOAM |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1992-08-31 |