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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 -2883
Applicant Contact DOUGLAS KWART
Correspondent
LEISEGANG MEDICAL, INC.
6401 CONGRESS AVE.
BOCA RATON,  FL  33487 -2883
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
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