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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 K932782
Device Name HM-0660
Applicant
HILL-MED, INC.
7217 N.W. 46TH ST.
MIAMI,  FL  33166
Applicant Contact ERNESTO ACKERMAN
Correspondent
HILL-MED, INC.
7217 N.W. 46TH ST.
MIAMI,  FL  33166
Correspondent Contact ERNESTO ACKERMAN
Regulation Number884.1630
Classification Product Code
HEX  
Date Received06/09/1993
Decision Date 03/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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