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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 K953793
Device Name INTROSCOPE
Applicant
POLAMEDCO, INC.
4054 GLENCOE AVE.
MARINA DEL REY,  CA  90292 -5608
Applicant Contact COREY SELMAN
Correspondent
POLAMEDCO, INC.
4054 GLENCOE AVE.
MARINA DEL REY,  CA  90292 -5608
Correspondent Contact COREY SELMAN
Regulation Number868.1920
Classification Product Code
BZT  
Date Received08/14/1995
Decision Date 11/29/1995
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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