The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Compact Exchange Device 5c4197.
| Device ID | K851208 |
| 510k Number | K851208 |
| Device Name: | COMPACT EXCHANGE DEVICE 5C4197 |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Julia A Meyer |
| Correspondent | Julia A 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 | 1985-03-26 |
| Decision Date | 1985-04-08 |