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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
510(k) Number K261811
Device Name PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
Applicant
PRIMED Medical Products, Inc.
200, 2003-91 St. SW
Edmonton,  CA T6X 0W8
Applicant Contact Mitra Fard
Correspondent
PRIMED Medical Products, Inc.
200, 2003-91 St. SW
Edmonton,  CA T6X 0W8
Correspondent Contact Mitra Fard
Regulation Number878.4040
Classification Product Code
QSO  
Subsequent Product Code
FYC  
Date Received06/01/2026
Decision Date 09/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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