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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K883135
Device Name PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)
Applicant
Pioneering Technologies, Inc.
143 Union Blvd., Suite 900
Lakewood,  CO  80228
Applicant Contact WRIGHT PHD
Correspondent
Pioneering Technologies, Inc.
143 Union Blvd., Suite 900
Lakewood,  CO  80228
Correspondent Contact WRIGHT PHD
Regulation Number870.4500
Classification Product Code
DWS  
Date Received07/26/1988
Decision Date 09/26/1988
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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