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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K942438
Device Name ALTAIR 6100 CASSETTE RECORDER
Applicant
Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact PAUL APPEL
Correspondent
Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact PAUL APPEL
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/20/1994
Decision Date 08/05/1994
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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