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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, nasal, oxygen
510(k) Number K863431
Device Name OXYGEN CANNULA EAR WRAP (STYLE A)
Applicant
SALTER LABS
P.O. BOX 608
ARVIN,  CA  93203
Applicant Contact JAMES N CURTI
Correspondent
SALTER LABS
P.O. BOX 608
ARVIN,  CA  93203
Correspondent Contact JAMES N CURTI
Regulation Number868.5340
Classification Product Code
CAT  
Date Received09/04/1986
Decision Date 09/18/1986
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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