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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K012869
Device Name GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
Applicant
GIMMI GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
GIMMI GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Codes
HDC   HET   HHO   KNA  
Date Received08/27/2001
Decision Date 03/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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