Cleared Traditional

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

K991827 · Ri Mos. S.R.L. · Obstetrics & Gynecology

Jul 1999

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K991827 is an FDA 510(k) clearance for the GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on July 19, 1999, 52 days after receiving the submission on May 28, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K991827 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 1999
Decision Date	July 19, 1999
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF