The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Dual Slim Port Implanted Port (0654970/0654940).
Device ID | K964066 |
510k Number | K964066 |
Device Name: | DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | C.R. BARD, INC. BARD ACCESS SYSTEMS 5425 W. AMELIA EARHART DRIVE Salt Lake City, UT 84116 |
Contact | Peggy Keiffer |
Correspondent | Peggy Keiffer C.R. BARD, INC. BARD ACCESS SYSTEMS 5425 W. AMELIA EARHART DRIVE Salt Lake City, UT 84116 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-10 |
Decision Date | 1997-03-06 |
Summary: | summary |