The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Capd Y Set 5c4354.
Device ID | K853550 |
510k Number | K853550 |
Device Name: | TRAVENOL CAPD Y SET 5C4354 |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Julia Meyer |
Correspondent | Julia Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-26 |
Decision Date | 1985-10-04 |