The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Baxa Addiseal.
Device ID | K832254 |
510k Number | K832254 |
Device Name: | BAXA ADDISEAL |
Classification | Container, I.v. |
Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-11 |
Decision Date | 1983-07-26 |