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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K831577
Device Name TRACHEA/CUFF INFLATOR W/PRESSURE #583
Applicant
MEDICAL ELECTRONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL ELECTRONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/17/1983
Decision Date 07/07/1983
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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