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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 K863439
Device Name INTRAUTERINE HEMOSTASIS BALLOON STENT
Applicant
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Applicant Contact BYRON WICKETT
Correspondent
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Correspondent Contact BYRON WICKETT
Regulation Number884.4530
Classification Product Code
KNA  
Date Received09/05/1986
Decision Date 06/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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