The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Iliac Crest Bone Marrow Aspiration Needle.
| Device ID | K953082 |
| 510k Number | K953082 |
| Device Name: | ILIAC CREST BONE MARROW ASPIRATION NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. BLDG. K Mcgaw Park, IL 60085 |
| Contact | Sharon Richter |
| Correspondent | Sharon Richter BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. BLDG. K Mcgaw Park, IL 60085 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-09-22 |