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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Noninvasive
510(k) Number K930512
Device Name SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
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 Number880.6740
Classification Product Code
GAZ  
Date Received02/01/1993
Decision Date 07/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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