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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K951353
Device Name HYBRID SURGICAL DEVICES, MODIFICIATION
Applicant
Laser Centers of America, Inc.
7840 Montgomery Rd.
Cincinnati,  OH  45236
Applicant Contact RICHARD L STUDER
Correspondent
Laser Centers of America, Inc.
7840 Montgomery Rd.
Cincinnati,  OH  45236
Correspondent Contact RICHARD L STUDER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GEX  
Date Received02/27/1995
Decision Date 04/06/1995
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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