FDA 510(k) Application Details - K200500

Device Classification Name Purifier, Air, Ultraviolet, Medical

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510(K) Number K200500
Device Name Purifier, Air, Ultraviolet, Medical
Applicant Molekule, Inc.
1301 Folsom St.
San Francisco, CA 94103 US
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Contact Frank Bianco
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Regulation Number 880.6500

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Classification Product Code FRA
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Date Received 02/28/2020
Decision Date 04/15/2020
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

FDA Source Information for K200500


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