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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 K883058
Device Name SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
Applicant
Solco Basle, Inc.
169 Weymouth St.
Rockland,  MA  02370
Applicant Contact ROBERT CUNNINGHAM
Correspondent
Solco Basle, Inc.
169 Weymouth St.
Rockland,  MA  02370
Correspondent Contact ROBERT CUNNINGHAM
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/19/1988
Decision Date 10/28/1988
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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