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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Natural-Absorbable Gelatin Material
510(k) Number K911212
Device Name LM-150HT LIGHT SOURCE
Applicant
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Applicant Contact DOUGLAS DWART
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Correspondent Contact DOUGLAS DWART
Classification Product Code
ESI  
Date Received03/19/1991
Decision Date 05/23/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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