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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 K132405
Device Name PPA/BT-RB STETHOSCOPE
Applicant
Rnk Products, Inc.
8247 Devereux Dr. Suite 101
Melbourne,  FL  32940
Applicant Contact CHARLES R ABBRUSCATO
Correspondent
Rnk Products, Inc.
8247 Devereux Dr. Suite 101
Melbourne,  FL  32940
Correspondent Contact CHARLES R ABBRUSCATO
Regulation Number870.1875
Classification Product Code
DQD  
Date Received08/02/2013
Decision Date 10/11/2013
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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