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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 K021153
Device Name GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
Applicant
GOLDWAY US, INC.
12 SOUTH FIRST STREET,
SUITE 1205
SAN JOSE,  CA  95113
Applicant Contact Y. JUSTIN CHEN
Correspondent
GOLDWAY US, INC.
12 SOUTH FIRST STREET,
SUITE 1205
SAN JOSE,  CA  95113
Correspondent Contact Y. JUSTIN CHEN
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/10/2002
Decision Date 02/10/2003
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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