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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K010473
Device Name SPARROWHAWK DISPOSABLE
Applicant
Atc Technologies, Inc.
80 Cummings Park
Woburn,  MA  01801
Applicant Contact PAUL KIERCE
Correspondent
Atc Technologies, Inc.
80 Cummings Park
Woburn,  MA  01801
Correspondent Contact PAUL KIERCE
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received02/20/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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