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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 K022868
Device Name PRIMAGARD SURGICAL EQUIPMENT DRAPES
Applicant
Primeline Medical Products, Inc.
10707-100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Applicant Contact BRENDA LEE
Correspondent
Primeline Medical Products, Inc.
10707-100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Correspondent Contact BRENDA LEE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/29/2002
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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