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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
510(k) Number K830329
Device Name ESOPHAGEAL STETHOSCOPE
Applicant
SCIENCE DEVELOPMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SCIENCE DEVELOPMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1910
Classification Product Code
BZW  
Date Received02/01/1983
Decision Date 03/11/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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