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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pessary, vaginal
510(k) Number K965040
Device Name INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Applicant Contact RALPH H LARSEN
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Correspondent Contact RALPH H LARSEN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received12/17/1996
Decision Date 03/10/1997
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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