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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 K980538
Device Name LASER LANCET LB100
Applicant
Transmedica Intl., Inc.
323 Center St., Suite 1100
Little Rock,  AR  72201
Applicant Contact Kevin Marchitto
Correspondent
Transmedica Intl., Inc.
323 Center St., Suite 1100
Little Rock,  AR  72201
Correspondent Contact Kevin Marchitto
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/11/1998
Decision Date 07/09/1998
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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