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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K851048
Device Name CHEST CATHETERS/THORACIC CATHETERS
Applicant
Medovations, Inc.
11311 W. Locust St.
Wauwatosa,  WI  53222
Applicant Contact SURY R SHONEY
Correspondent
Medovations, Inc.
11311 W. Locust St.
Wauwatosa,  WI  53222
Correspondent Contact SURY R SHONEY
Regulation Number878.4200
Classification Product Code
GBS  
Date Received03/14/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
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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