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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 K914519
Device Name DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC
Applicant
Dio-Med Corp.
St. John'S Innovation Park
Cowley Rd.
Cambridge Cb4 4ws England,  GB
Applicant Contact ILKKA MANNONEN
Correspondent
Dio-Med Corp.
St. John'S Innovation Park
Cowley Rd.
Cambridge Cb4 4ws England,  GB
Correspondent Contact ILKKA MANNONEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/10/1991
Decision Date 09/16/1993
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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