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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
Applicant Contact RALPH H LARSEN
Correspondent
Johnson & Johnson Medical, Inc.
2500 Arbrook Blvd.
P.O. Box 90130
Arlington,  TX  76004
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
Predetermined Change
Control Plan Authorized		 No
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