The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Implantofix.
| Device ID | K851293 |
| 510k Number | K851293 |
| Device Name: | IMPLANTOFIX |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1986-01-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMPLANTOFIX 73697621 1493012 Dead/Cancelled |
B. BRAUN MELSUNGEN AKTIENGESELLSCHAFT 1987-11-25 |