The following data is part of a premarket notification filed by Delaware Prosthetics, Inc. with the FDA for Pdm Siloxane Prosthetic Ear.
| Device ID | K832152 |
| 510k Number | K832152 |
| Device Name: | PDM SILOXANE PROSTHETIC EAR |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | DELAWARE PROSTHETICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-05 |
| Decision Date | 1983-12-09 |