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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K160361
Device Name PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
Applicant
Primed Medical Products, Inc.
3rd Floor, 1259-91 St. Sw.
Edmonton,  CA T6X1E9
Applicant Contact RICHARD R ROY
Correspondent
Primed Medical Products, Inc.
3rd Floor, 1259-91 St. Sw.
Edmonton,  CA T6X1E9
Correspondent Contact RICHARD R ROY
Regulation Number878.4040
Classification Product Code
FYC  
Date Received02/09/2016
Decision Date 11/04/2016
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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