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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 K993828
Device Name CERALAS D10 810NM DIODE LASER
Applicant
Ceram Optec, Inc.
515 Shaker Rd.
East Longmeadow,  MA  01028
Applicant Contact CAROL J MORELLO
Correspondent
Ceram Optec, Inc.
515 Shaker Rd.
East Longmeadow,  MA  01028
Correspondent Contact CAROL J MORELLO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/12/1999
Decision Date 02/01/2000
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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