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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 K992544
Device Name TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
Applicant
CIRCON CORP.
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Applicant Contact RONALD J EHMSEN
Correspondent
CIRCON CORP.
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Correspondent Contact RONALD J EHMSEN
Regulation Number884.1630
Classification Product Code
HEX  
Date Received07/30/1999
Decision Date 10/26/1999
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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