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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 K913421
Device Name NASAL OXYGEN CANNULA, 81585, 81587 & 81589
Applicant
SPECIALTY PACKAGING PRODUCS, INC.
19 LEIGH FISHER
EL PASO,  TX  79906
Applicant Contact EDWARD F VALDEZ
Correspondent
SPECIALTY PACKAGING PRODUCS, INC.
19 LEIGH FISHER
EL PASO,  TX  79906
Correspondent Contact EDWARD F VALDEZ
Regulation Number868.5340
Classification Product Code
CAT  
Date Received07/31/1991
Decision Date 10/18/1991
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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