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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K902313
Device Name LM-1Z ZOOM SCOPE
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 Number884.1630
Classification Product Code
HEX  
Date Received05/23/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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