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 |