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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K032704
Device Name INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
Applicant
Innovatech Surgical, Inc.
1000 Atlantic Ave.
Suite 514
Camden,  NJ  08104
Applicant Contact MICHAEL J MCGOWAN
Correspondent
Innovatech Surgical, Inc.
1000 Atlantic Ave.
Suite 514
Camden,  NJ  08104
Correspondent Contact MICHAEL J MCGOWAN
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQF  
Date Received09/02/2003
Decision Date 10/24/2003
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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