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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 K981126
Device Name CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3
Applicant
Ceram Optec, Inc.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHANM ESQ.
Correspondent
Ceram Optec, Inc.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHANM ESQ.
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/27/1998
Decision Date 06/25/1998
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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