The following data is part of a premarket notification filed by Trans-national Trade Development Corp. with the FDA for Idecap Dialyzer.
| Device ID | K852764 |
| 510k Number | K852764 |
| Device Name: | IDECAP DIALYZER |
| Classification | Dialyzer, Disposable |
| Applicant | TRANS-NATIONAL TRADE DEVELOPMENT CORP. 2 DAG HAMMARSKJOLD PLAZA 866 SECOND AVENUE New York, NY 10017 |
| Contact | Robert Keller |
| Correspondent | Robert Keller TRANS-NATIONAL TRADE DEVELOPMENT CORP. 2 DAG HAMMARSKJOLD PLAZA 866 SECOND AVENUE New York, NY 10017 |
| Product Code | FJH |
| CFR Regulation Number | 876.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1985-09-20 |