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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 K893436
Device Name MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
Applicant
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact WRIGHT,PHD
Correspondent
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact WRIGHT,PHD
Regulation Number870.4500
Classification Product Code
DWS  
Date Received05/03/1989
Decision Date 07/14/1989
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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