The following data is part of a premarket notification filed by Dekumed, Kunststofftechnik Degler Gmbh with the FDA for Calssique Or Mystique.
| Device ID | K932978 |
| 510k Number | K932978 |
| Device Name: | CALSSIQUE OR MYSTIQUE |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | DEKUMED, KUNSTSTOFFTECHNIK DEGLER GMBH AM ANGER 27 8214 BERNAU Germany, DE |
| Contact | Peter Rickauer |
| Correspondent | Peter Rickauer DEKUMED, KUNSTSTOFFTECHNIK DEGLER GMBH AM ANGER 27 8214 BERNAU Germany, DE |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-17 |
| Decision Date | 1993-12-22 |