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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 K032969
Device Name HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE
Applicant
Helica Instruments, Ltd.
1020 W. Bay Ave.
Newport Beach,  CA  92661
Applicant Contact JOHN B WEBB
Correspondent
Helica Instruments, Ltd.
1020 W. Bay Ave.
Newport Beach,  CA  92661
Correspondent Contact JOHN B WEBB
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/2003
Decision Date 02/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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