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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Heart-Valve, Prosthesis
510(k) Number K944214
Device Name BAXTER HANDLE MODEL 1150
Applicant
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Applicant Contact EASTER SALTZ
Correspondent
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Correspondent Contact EASTER SALTZ
Regulation Number870.3935
Classification Product Code
DTJ  
Date Received08/29/1994
Decision Date 02/10/1995
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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