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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 K221209
Device Name PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
Applicant
Padm Medical, Inc.
1595 Buffalo Place
Winnipeg,  CA R3T 1L9
Applicant Contact Xiomara Perdomo
Correspondent
Padm Medical, Inc.
1595 Buffalo Place
Unit A
Winnipeg,  CA R3T 1L9
Correspondent Contact Pablo Batista
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/26/2022
Decision Date 03/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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