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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 K882479
Device Name 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP
Applicant
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact DENNIE E DYER
Correspondent
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact DENNIE E DYER
Regulation Number870.4500
Classification Product Code
DWS  
Date Received06/16/1988
Decision Date 07/18/1988
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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