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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 K940094
Device Name COLPOSCOPES AND ACCESSORIES
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 Received01/07/1994
Decision Date 04/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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