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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853927
Device Name LASE SYSTEM II
Applicant
James L. Geraci & Associates, Inc.
P.O. Box 41291
Cincinnati,  OH  45241
Applicant Contact JAMES GERACI
Correspondent
James L. Geraci & Associates, Inc.
P.O. Box 41291
Cincinnati,  OH  45241
Correspondent Contact JAMES GERACI
Date Received09/24/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
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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