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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K915867
Device Name SOLCOVAC WOUND DRAINAGE SYSTEM
Applicant
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Applicant Contact ROBERT W CUNNINGHAM
Correspondent
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Correspondent Contact ROBERT W CUNNINGHAM
Regulation Number878.4680
Classification Product Code
GCY  
Date Received12/31/1991
Decision Date 08/14/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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