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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K931138
Device Name CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP
Applicant
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Applicant Contact BILL DENNIS
Correspondent
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Correspondent Contact BILL DENNIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/05/1993
Decision Date 09/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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