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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 K970889
Device Name ULTRASOUND TRANSDUCER DRAPE
Applicant
Protek Medical Products, Inc.
221 E. Market St. Suite 291
Iowa City,  IA  52245
Applicant Contact RICK L PRUTER
Correspondent
Protek Medical Products, Inc.
221 E. Market St. Suite 291
Iowa City,  IA  52245
Correspondent Contact RICK L PRUTER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/11/1997
Decision Date 10/20/1997
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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