The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Bone Marrow Collection Kit And Stand.
Device ID | K871198 |
510k Number | K871198 |
Device Name: | BONE MARROW COLLECTION KIT AND STAND |
Classification | Bone Marrow Collection/transfusion Kit |
Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
Contact | Buchholz, Md |
Correspondent | Buchholz, Md BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
Product Code | LWE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-24 |
Decision Date | 1987-11-06 |