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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 K935258
Device Name HYBRID SURGICAL DEVICE MODIFICATION
Applicant
Lca, Inc.
1101 St. Gregory St.
Cincinnati,  OH  45202
Applicant Contact RICHARD L STUDER
Correspondent
Lca, Inc.
1101 St. Gregory St.
Cincinnati,  OH  45202
Correspondent Contact RICHARD L STUDER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/01/1993
Decision Date 01/13/1994
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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