PKG — Bone Marrow Processing Device To Support Hematopoietic Reconstitution Class II
FDA product code PKG covers "Bone Marrow Processing Device To Support Hematopoietic Reconstitution", a Class II medical device regulated under 21 CFR 864.9245. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- PKG
- Device Class
- Class II
- Regulation Number
- 864.9245
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.