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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 K043377
Device Name ZENO
Applicant
Tyrell, Inc.
2202 Timberloch Place
Suite 230
Woodlands,  TX  77380
Applicant Contact DARLA J ELKIN
Correspondent
Tyrell, Inc.
2202 Timberloch Place
Suite 230
Woodlands,  TX  77380
Correspondent Contact DARLA J ELKIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/08/2004
Decision Date 06/01/2005
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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