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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 K843821
Device Name SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS
Applicant
Solco Basle, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Solco Basle, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/28/1984
Decision Date 10/01/1985
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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