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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 K960426
Device Name MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact MICHELLE DEMERS
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact MICHELLE DEMERS
Regulation Number878.4200
Classification Product Code
GBW  
Date Received01/29/1996
Decision Date 03/21/1996
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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