The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Jobskin Continuing Care.
Device ID | K925583 |
510k Number | K925583 |
Device Name: | JOBSKIN CONTINUING CARE |
Classification | Elastomer, Silicone, For Scar Management |
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 | MDA |
CFR Regulation Number | 878.4025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-05 |
Decision Date | 1994-04-04 |