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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, manual, specialized obstetric-gynecologic
510(k) Number K982464
Device Name SCC-23 SAFETY CLAMP AND CUTTER
Applicant
WOMEN FIRST HEALTHCARE, INC.
12220 EL CAMINO REAL,
SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact JEANNE-MARIE VARGE
Correspondent
WOMEN FIRST HEALTHCARE, INC.
12220 EL CAMINO REAL,
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact JEANNE-MARIE VARGE
Regulation Number884.4530
Classification Product Code
KNA  
Date Received07/15/1998
Decision Date 08/11/1998
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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