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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, fixation, tracheal tube
510(k) Number K882694
Device Name FIXATION DEVICE, TRACH TUBE
Applicant
BIOSEAL
350 NORTH PALM
BREA,  CA  92621
Applicant Contact WILLIAM L RUNION
Correspondent
BIOSEAL
350 NORTH PALM
BREA,  CA  92621
Correspondent Contact WILLIAM L RUNION
Regulation Number868.5770
Classification Product Code
CBH  
Date Received06/27/1988
Decision Date 08/15/1988
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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