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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K843071
Device Name ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
Applicant
PRIMROSE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRIMROSE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1920
Classification Product Code
BZT  
Date Received08/06/1984
Decision Date 08/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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