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GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043

K991827 Class II Traditional
Decision Date
1999-07-19
Sponsor / Applicant
Ri Mos. S.R.L.

Technical Specification

510(k) Submission ID K991827
Product Code HIB
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.4530
Decision Date 1999-07-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 received FDA 510(k) clearance under submission number K991827, sponsored by Ri Mos. S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-07-19.

Classification & Regulation

This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.