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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, autotransfusion
510(k) Number K912019
Device Name ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
Applicant
GISH BIOMEDICAL, INC.
2350 S. PULLMAN AVE.
SANTA ANA,  CA  92705
Applicant Contact DEBI KRIDNER
Correspondent
GISH BIOMEDICAL, INC.
2350 S. PULLMAN AVE.
SANTA ANA,  CA  92705
Correspondent Contact DEBI KRIDNER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/07/1991
Decision Date 10/08/1991
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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