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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K973958
Device Name GENERAL PURPOSE ATL NEEDLE GUIDE KIT
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 Number892.1570
Classification Product Code
ITX  
Date Received10/16/1997
Decision Date 01/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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