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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen
510(k) Number K865047
Device Name SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
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 Number868.5580
Classification Product Code
BYG  
Date Received12/24/1986
Decision Date 02/10/1987
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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