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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
510(k) Number K991827
Device Name GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
Applicant
RI MOS. S.R.L.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Applicant Contact ADENA NORA S RIEMER
Correspondent
RI MOS. S.R.L.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Correspondent Contact ADENA NORA S RIEMER
Regulation Number884.4530
Classification Product Code
HIB  
Date Received05/28/1999
Decision Date 07/19/1999
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
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