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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 K033870
Device Name IMAGE MANAGEMENT SYSTEM
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number884.1630
Classification Product Code
HEX  
Subsequent Product Code
LMA  
Date Received12/12/2003
Decision Date 03/12/2004
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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