The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Aspirator, Manuel.
Device ID | K780208 |
510k Number | K780208 |
Device Name: | ASPIRATOR, MANUEL |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-07 |
Decision Date | 1978-03-03 |