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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 K890471
Device Name PMS ANGIO DRAPE
Applicant
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/31/1989
Decision Date 02/27/1989
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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