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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K924410
Device Name LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION
Applicant
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Applicant Contact BILL DENNIS
Correspondent
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Correspondent Contact BILL DENNIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/31/1992
Decision Date 06/25/1993
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
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