The following data is part of a premarket notification filed by Surgical Appliance Industries, Inc. with the FDA for External Breast Prosthesis.
| Device ID | K813416 |
| 510k Number | K813416 |
| Device Name: | EXTERNAL BREAST PROSTHESIS |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | SURGICAL APPLIANCE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1982-01-18 |