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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
Applicant
Molekule, Inc.
1301 Folsom St.
San Francisco,  CA  94103
Applicant Contact Frank Bianco
Correspondent
Hymann, Phelps, & Mcnamara P.C.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne R. Lenz
Regulation Number880.6500
Classification Product Code
FRA  
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
Predetermined Change
Control Plan Authorized		 No
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