BONE MARROW COLLECTION KIT AND STAND
Device Facts
| Record ID | K871198 |
|---|---|
| Device Name | BONE MARROW COLLECTION KIT AND STAND |
| Applicant | Baxter Healthcare Corp |
| Product Code | LWE · HO |
| Decision Date | Nov 6, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class 2 |
Regulatory Classification
Identification
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
