Cleared Traditional

MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE

K951835 · Life Technologies, Inc. · Obstetrics & Gynecology

Aug 1995

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K951835 is an FDA 510(k) clearance for the MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Life Technologies, Inc. (Grand Island, US). The FDA issued a Cleared decision on August 11, 1995, 113 days after receiving the submission on April 20, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number	K951835 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 1995
Decision Date	August 11, 1995
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF