ICR Documents

Supporting Statement A Document Date Uploaded 0844 De Novo Device Classifications SSA DEC 2021.docx 12/02/2021 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded CDRH De Novo Device FRIA FRIA De Novo Device Classification Process OCT 2021.pdf Supplementary Document 11/22/2021 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received