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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, intrauterine insemination
510(k) Number K910577
Device Name EDWARDS-WALLACE BOURNE HALL CATHETER
Applicant
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Applicant Contact SCOTT C MARLOW
Correspondent
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Correspondent Contact SCOTT C MARLOW
Regulation Number884.5250
Classification Product Code
MFD  
Date Received02/11/1991
Decision Date 05/09/1991
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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