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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 K970891
Device Name DRAPE, SURGICAL-LATEX
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 08/22/1997
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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