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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 K880497
Device Name WORD BARTHOLIN GLAND CATHETER CODE: 1005
Applicant
HOOSIER SPECIALTIES, INC.
RURAL ROUTE #5
POST OFFICE BOX 424
SULLIVAN,  IN  47882
Applicant Contact SHERRY PARR
Correspondent
HOOSIER SPECIALTIES, INC.
RURAL ROUTE #5
POST OFFICE BOX 424
SULLIVAN,  IN  47882
Correspondent Contact SHERRY PARR
Regulation Number884.4530
Classification Product Code
KNA  
Date Received02/05/1988
Decision Date 03/24/1988
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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