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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K943368
Device Name TRU-CORE NEEDLE SET
Applicant
Ideamatrix
3321 Rockwood Ln. S.
Estes Park,  CO  80517
Applicant Contact RICHARD TERWILLIGER
Correspondent
Ideamatrix
3321 Rockwood Ln. S.
Estes Park,  CO  80517
Correspondent Contact RICHARD TERWILLIGER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/13/1994
Decision Date 07/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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