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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 K934008
Device Name MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST
Applicant
Ceram Optec, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KALHAN
Correspondent
Ceram Optec, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KALHAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/17/1993
Decision Date 01/03/1994
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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