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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stethoscope, fetal
510(k) Number K761338
Device Name LEFF STETHOSCOPE FOR FETAL HEART
Applicant
J. SKLAR MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
J. SKLAR MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2900
Classification Product Code
HGN  
Date Received12/27/1976
Decision Date 01/12/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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