Cleared Traditional

TOM CAT F.L., TOM CAT S.L.

K972245 · A & A Medical, Inc. · Obstetrics & Gynecology
Aug 1997
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K972245 is an FDA 510(k) clearance for the TOM CAT F.L., TOM CAT S.L., 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 August 6, 1997, 51 days after receiving the submission on June 16, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K972245 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1997
Decision Date August 06, 1997
Days to Decision 51 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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