The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Sterile Cormed Mediport.
| Device ID | K850967 |
| 510k Number | K850967 |
| Device Name: | STERILE CORMED MEDIPORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Contact | Eric P Ankerud |
| Correspondent | Eric P Ankerud CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1985-05-17 |