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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 K904841
Device Name LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED
Applicant
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Applicant Contact ROBERT J ANSELMO
Correspondent
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact ROBERT J ANSELMO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/24/1990
Decision Date 04/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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