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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 K111359
Device Name SHEAUMANN PL-1064
Applicant
Sheaumann Lasers
189 Winding Oaks Ln.
Oviedo,  FL  32765
Applicant Contact TIMOTHY J SHEA
Correspondent
Sheaumann Lasers
189 Winding Oaks Ln.
Oviedo,  FL  32765
Correspondent Contact TIMOTHY J SHEA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/16/2011
Decision Date 09/13/2011
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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