The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Baxter Single Patient Use Pressure Infusor.
Device ID | K904484 |
510k Number | K904484 |
Device Name: | BAXTER SINGLE PATIENT USE PRESSURE INFUSOR |
Classification | Infusor, Pressure, For I.v. Bags |
Applicant | TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach, FL 32960 |
Contact | John Garrett |
Correspondent | John Garrett TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach, FL 32960 |
Product Code | KZD |
CFR Regulation Number | 880.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-02 |
Decision Date | 1990-10-26 |