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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K023117
Device Name PRIMAGARD SURGICAL GOWNS
Applicant
Primeline Medical Products, Inc.
10707 100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Applicant Contact BRANDA LEE
Correspondent
Primeline Medical Products, Inc.
10707 100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Correspondent Contact BRANDA LEE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/11/2002
Decision Date 11/08/2002
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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