The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Transducer Protector.
Device ID | K772040 |
510k Number | K772040 |
Device Name: | TRANSDUCER PROTECTOR |
Classification | Filter, Blood, Dialysis |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKJ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-28 |
Decision Date | 1977-11-28 |