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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 K032944
Device Name YA-MAN LASER 21
Applicant
Ya-Man, Ltd.
5818 Princess Caroline Pl.
Leesburg,  FL  34748
Applicant Contact ROBERT T HANDREN
Correspondent
Ya-Man, Ltd.
5818 Princess Caroline Pl.
Leesburg,  FL  34748
Correspondent Contact ROBERT T HANDREN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/22/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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