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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 K951933
Device Name UROTEK RE-USABLE FIBEROPTIC CABLE
Applicant
Energy Life Systems Corp.
3303 Harbor Blvd., Unit D-13
Costa Mesa,  CA  92626
Applicant Contact HANY HUSSEIN
Correspondent
Energy Life Systems Corp.
3303 Harbor Blvd., Unit D-13
Costa Mesa,  CA  92626
Correspondent Contact HANY HUSSEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/25/1995
Decision Date 05/26/1995
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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