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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 K034046
Device Name RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
Applicant
Rnk Products
12700 Diamond Dr.
Burnsville,  MN  55337
Applicant Contact CHARLES R ABBRUSCATO
Correspondent
Rnk Products
12700 Diamond Dr.
Burnsville,  MN  55337
Correspondent Contact CHARLES R ABBRUSCATO
Regulation Number870.1875
Classification Product Code
DQD  
Date Received12/29/2003
Decision Date 03/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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