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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K023173
Device Name ANDREWS INTRODUCER, MODEL ASI01
Applicant
Andrews Surgical Innovations, Ltd.
16 Grove Lawn
Malahide
Co. Dublin,  IE
Applicant Contact EMMET ANDREWS
Correspondent
Andrews Surgical Innovations, Ltd.
16 Grove Lawn
Malahide
Co. Dublin,  IE
Correspondent Contact EMMET ANDREWS
Regulation Number878.4800
Classification Product Code
MDM  
Date Received09/23/2002
Decision Date 12/18/2002
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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