The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Celsite Implantable Port With Valved Catheter.
Device ID | K993024 |
510k Number | K993024 |
Device Name: | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown, PA 18103 |
Contact | Mark S Alsberge |
Correspondent | Mark S Alsberge B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown, PA 18103 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-09 |
Decision Date | 2000-03-13 |
Summary: | summary |