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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 K923327
Device Name STETHOSCOPE COVER
Applicant
Anup Chakraborty Co.
6510 Ponderosa Cir.
Lincoln,  NE  68510
Applicant Contact ANUP CHAKRABORTY
Correspondent
Anup Chakraborty Co.
6510 Ponderosa Cir.
Lincoln,  NE  68510
Correspondent Contact ANUP CHAKRABORTY
Regulation Number870.1875
Classification Product Code
LDE  
Date Received07/07/1992
Decision Date 11/03/1992
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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