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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 K860473
Device Name DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE
Applicant
Schering Corp.
2000 Galloping Hill Rd.
Kenilworth,  NJ  07033
Applicant Contact ALEXANDER GIAQUINTO
Correspondent
Schering Corp.
2000 Galloping Hill Rd.
Kenilworth,  NJ  07033
Correspondent Contact ALEXANDER GIAQUINTO
Regulation Number870.1875
Classification Product Code
LDE  
Date Received02/06/1986
Decision Date 08/14/1986
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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