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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name purifier, air, ultraviolet, medical
510(k) Number K211194
Device Name Molekule Air Pro
Molekule, Inc.
1301 Folsom St.
San Francisco,  CA  94103
Applicant Contact Frank Bianco
Hymann, Phelps, & McNamara, P.C.
700 Thirteenth Street, N.W., Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne R. Lenz
Regulation Number880.6500
Classification Product Code
Date Received04/21/2021
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No