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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K201137
Device Name Asept Surgical Face Mask
Applicant
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Applicant Contact Jessica Jho
Correspondent
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Correspondent Contact Jessica Jho
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/28/2020
Decision Date 08/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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