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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 K903539
Device Name SALTER LABS MODEL #1015
Applicant
SALTER LABS
P.O. BOX 608
ARVIN,  CA  93203
Applicant Contact JAMES N CLURTI
Correspondent
SALTER LABS
P.O. BOX 608
ARVIN,  CA  93203
Correspondent Contact JAMES N CLURTI
Regulation Number868.5770
Classification Product Code
CBH  
Date Received08/07/1990
Decision Date 12/17/1990
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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