FDA 510(k) Application Details - K211194

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K211194
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	Molekule, Inc. 1301 Folsom St. San Francisco, CA 94103 US Other 510(k) Applications for this Company
Contact	Frank Bianco Other 510(k) Applications for this Contact
Regulation Number	880.6500   More FDA Info for this Regulation Number
Classification Product Code	FRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2021
Decision Date	08/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review