Cleared Traditional

MI-MARK ENDOCERVICAL SAMPLING SET

K790923 · Simpson/Basye, Inc. · Obstetrics & Gynecology
Jun 1979
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K790923 is an FDA 510(k) clearance for the MI-MARK ENDOCERVICAL SAMPLING SET, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Simpson/Basye, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1979, 38 days after receiving the submission on May 15, 1979. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K790923 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1979
Decision Date June 22, 1979
Days to Decision 38 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code KNA — Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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