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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K875241
Device Name CIVCO SEED IMPLANT NEEDLE GUIDE
Applicant
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Applicant Contact VICTOR WEDEL
Correspondent
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Correspondent Contact VICTOR WEDEL
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/22/1987
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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