PKG

Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Product code: PKG
Device name: Bone Marrow Processing Device To Support Hematopoietic Reconstitution
Device class: Class 2
21 CFR: 21 CFR 864.9245
Medical specialty: Hematology
Marketing pathway: 510(K)

FDA classification definition

Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PKG

Classification and pathway per current FDA publications. Data from openFDA (CC0).