The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Tray, Auxillary Block.
Device ID | K782069 |
510k Number | K782069 |
Device Name: | TRAY, AUXILLARY BLOCK |
Classification | Anesthesia Conduction Kit |
Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-13 |
Decision Date | 1979-01-04 |