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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 K202339
Device Name Molekule Air Mini, Molekule Air Mini +
Molekule, Inc.
1301 Folsom St.
san francisco,  CA  94103
Applicant Contact frank bianco
Hyman, 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 Received08/17/2020
Decision Date 02/23/2021
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