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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 K000707
Device Name LEICA COLPOSCOPE
Applicant
LEICA MICROSCOPY SYSTEMS LTD.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
LEICA MICROSCOPY SYSTEMS LTD.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number884.1630
Classification Product Code
HEX  
Date Received03/02/2000
Decision Date 06/27/2000
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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