Cleared Traditional

MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER

K972823 · A & A Medical, Inc. · Obstetrics & Gynecology
Oct 1997
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K972823 is an FDA 510(k) clearance for the MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 10, 1997, 72 days after receiving the submission on July 30, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K972823 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1997
Decision Date October 10, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MFD — Cannula, Intrauterine Insemination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250

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