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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K760453
Device Name REGULATOR, PRESSURE, CUFF
Applicant
BOEHRINGER LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BOEHRINGER LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5800
Classification Product Code
JOH  
Date Received08/16/1976
Decision Date 09/13/1976
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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