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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Endoscopic
510(k) Number K913135
Device Name LM-300TWIN
Applicant
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Applicant Contact DOUGLAS KWART
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Correspondent Contact DOUGLAS KWART
Regulation Number878.4580
Classification Product Code
FSW  
Date Received07/16/1991
Decision Date 09/18/1991
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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