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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K053583
Device Name OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
Applicant
OPTIVIA MEDICAL LLC
101 N. CHESTNUT STREET
SUITE 305
WINSTON-SALEM,  NC  27101
Applicant Contact ROBERT M KELLEY
Correspondent
OPTIVIA MEDICAL LLC
101 N. CHESTNUT STREET
SUITE 305
WINSTON-SALEM,  NC  27101
Correspondent Contact ROBERT M KELLEY
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/23/2005
Decision Date 03/31/2006
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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