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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tent, oxygen
510(k) Number K896608
Device Name SPAG PAK
Applicant
VIRATEK, INC.
ICN PLAZA
3300 HYLAND AVENUE
COSTA MESA,  CA  92626
Applicant Contact ALICE M WEI
Correspondent
VIRATEK, INC.
ICN PLAZA
3300 HYLAND AVENUE
COSTA MESA,  CA  92626
Correspondent Contact ALICE M WEI
Regulation Number868.5700
Classification Product Code
BYL  
Date Received11/21/1989
Decision Date 04/09/1990
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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