The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Intestoplant.
| Device ID | K862412 |
| 510k Number | K862412 |
| Device Name: | INTESTOPLANT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Tracey Yakabow |
| Correspondent | Tracey Yakabow BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | LLD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1986-11-13 |