The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for Transducer Protector.
Device ID | K904912 |
510k Number | K904912 |
Device Name: | TRANSDUCER PROTECTOR |
Classification | Protector, Transducer, Dialysis |
Applicant | FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
Contact | Larry Larkin |
Correspondent | Larry Larkin FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
Product Code | FIB |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-31 |
Decision Date | 1991-01-04 |