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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal
510(k) Number K894119
Device Name MADEGOM LTDA. PENROSE DRAIN TUBING
Applicant
Madegom
Casilla Postal 85
11 Santiago
Chile,  CL
Applicant Contact ALEJANDRO MIRALLES
Correspondent
Madegom
Casilla Postal 85
11 Santiago
Chile,  CL
Correspondent Contact ALEJANDRO MIRALLES
Regulation Number878.4200
Classification Product Code
GBW  
Date Received06/12/1989
Decision Date 08/18/1989
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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