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 |