The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Port-gard.
Device ID | K854019 |
510k Number | K854019 |
Device Name: | PORT-GARD |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
Contact | Eric Ankerud |
Correspondent | Eric 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 | 1985-09-30 |
Decision Date | 1985-11-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PORT-GARD 73607900 1485882 Dead/Cancelled |
CORMED, INC. 1986-07-07 |