The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Yours Truly Asymmetrical Breast Form.
| Device ID | K911247 |
| 510k Number | K911247 |
| Device Name: | YOURS TRULY ASYMMETRICAL BREAST FORM |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
| Contact | Bruce W Wetzel |
| Correspondent | Bruce W Wetzel JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-03-29 |