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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 K913275
Device Name VENTURI OXYGEN MASK
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 Number868.5580
Classification Product Code
BYG  
Date Received07/23/1991
Decision Date 10/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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