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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 K926477
Device Name BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
Applicant
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Applicant Contact TIM REIS
Correspondent
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Correspondent Contact TIM REIS
Regulation Number878.4200
Classification Product Code
GBW  
Date Received12/29/1992
Decision Date 11/12/1993
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
Recalls CDRH Recalls
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