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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K860994
Device Name DECITEL AUSCULSCOPE
Applicant
Bloomfield Research and Development, Inc.
P.O. Box 23980
Hilton Head,  SC  29925
Applicant Contact DAVID LIVELY
Correspondent
Bloomfield Research and Development, Inc.
P.O. Box 23980
Hilton Head,  SC  29925
Correspondent Contact DAVID LIVELY
Regulation Number870.1875
Classification Product Code
DQD  
Date Received03/17/1986
Decision Date 11/07/1986
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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