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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 K031639
Device Name INTERMED ZOOM COLPOSCOPE
Applicant
INTERMED GROUP, INC.
3550 23RD AVE. SOUTH, SUITE #1
LAKE WORTH,  FL  33461
Applicant Contact GEORGE GARAMY, JR.
Correspondent
INTERMED GROUP, INC.
3550 23RD AVE. SOUTH, SUITE #1
LAKE WORTH,  FL  33461
Correspondent Contact GEORGE GARAMY, JR.
Regulation Number884.1630
Classification Product Code
HEX  
Date Received05/27/2003
Decision Date 08/22/2003
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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