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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name speculum, vaginal, nonmetal, fiberoptic
510(k) Number K902516
Device Name NEW LENGTH SUGITA APPLIERS
Applicant
SIMS SURGICAL, INC.
15 KIT ST.
P.O. BOX 724
KEENE,  NH  03431
Applicant Contact JOHN D FORSTER
Correspondent
SIMS SURGICAL, INC.
15 KIT ST.
P.O. BOX 724
KEENE,  NH  03431
Correspondent Contact JOHN D FORSTER
Regulation Number884.4530
Classification Product Code
HIC  
Date Received06/07/1990
Decision Date 07/03/1990
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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