The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Automatic Peritoneal Dialysis Cycler Set (5c4437).
Device ID | K873984 |
510k Number | K873984 |
Device Name: | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Contact | Robert L Wilkinson |
Correspondent | Robert L Wilkinson TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Product Code | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-30 |
Decision Date | 1987-10-20 |