The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Gillam-tukel Bone Marrow Biopsy Needle.
| Device ID | K924501 |
| 510k Number | K924501 |
| Device Name: | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | Kevin W Smith |
| Correspondent | Kevin W Smith SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1993-04-20 |