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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 K890565
Device Name GELLHORN PESSARY 33410 VARIOUS SIZES
Applicant
MEDI-SOURCE, INC.
50 GORDON DR.
P.O. BOX 874
SYOSSET,  NY  11791
Applicant Contact ANDREW GALAMBOS
Correspondent
MEDI-SOURCE, INC.
50 GORDON DR.
P.O. BOX 874
SYOSSET,  NY  11791
Correspondent Contact ANDREW GALAMBOS
Regulation Number884.3575
Classification Product Code
HHW  
Date Received02/06/1989
Decision Date 03/29/1989
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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