The following data is part of a premarket notification filed by Medeering, Ltd. with the FDA for Trulife Silicone Breast Form.
Device ID | K831831 |
510k Number | K831831 |
Device Name: | TRULIFE SILICONE BREAST FORM |
Classification | Material, External Aesthetic Restoration, Used With Adhesive |
Applicant | MEDEERING, LTD. 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 | 1983-06-07 |
Decision Date | 1983-06-30 |