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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K945921
Device Name ECHO STAR NEEDLE SET
Applicant
IDEAMATRIX
3321 ROCKWOOD LN. SOUTH
ESTES PARK,  CO  80517
Applicant Contact RICHARD TERWILLIGER
Correspondent
IDEAMATRIX
3321 ROCKWOOD LN. SOUTH
ESTES PARK,  CO  80517
Correspondent Contact RICHARD TERWILLIGER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/05/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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