Brief: Celularity Receives Preliminary Assessment Of Product Classification And Jurisdiction For Its Investigational Celularity Tendon Wrap (CTW)

Celularity

01/02/2023 22:57

Feb 1 (Reuters) - Celularity Inc  CELU.O :
    * CELULARITY RECEIVES PRELIMINARY ASSESSMENT OF PRODUCT
CLASSIFICATION AND JURISDICTION FOR ITS INVESTIGATIONAL
CELULARITY TENDON WRAP (CTW) TO BE REGULATED  AS A DEVICE WITHIN
U.S. FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH (CDRH)
    * CELULARITY INC - CELULARITY TO SUBMIT 510(K) PRE-MARKET
NOTIFICATION TO FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
(CDRH)
    * CELULARITY INC - INTENDS TO SUBMIT A 510(K) APPLICATION
FOR
REGULATORY CLEARANCE TO CDRH BY END OF 2023.

Source text for Eikon:  ID:nGNX1hrNXN 
Further company coverage:  CELU.O 
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