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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Manual
510(k) Number K890126
Device Name KAMED STETHOSCOPE
Applicant
D.R.G.
P.O. Box 1178
Mountainside,  NJ  07092
Applicant Contact ALLAN KORN
Correspondent
D.R.G.
P.O. Box 1178
Mountainside,  NJ  07092
Correspondent Contact ALLAN KORN
Regulation Number870.1875
Classification Product Code
LDE  
Date Received01/12/1989
Decision Date 04/21/1989
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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