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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 K122973
Device Name AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
Applicant
MEDGYN PRODUCTS, INC.
12 SOUTH FIRST STREE
12TH FLOOR
SAN JOSE,  CA  95113
Applicant Contact STEPHANIE BLAIR
Correspondent
MEDGYN PRODUCTS, INC.
12 SOUTH FIRST STREE
12TH FLOOR
SAN JOSE,  CA  95113
Correspondent Contact STEPHANIE BLAIR
Regulation Number884.1630
Classification Product Code
HEX  
Date Received09/26/2012
Decision Date 06/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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