Cleared Traditional

K021193 - FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
(FDA 510(k) Clearance)

K021193 · Fortune Medical Instrument Corp. · Obstetrics & Gynecology
Feb 2003
Decision
303d
Days
Class 2
Risk

K021193 is an FDA 510(k) clearance for the FORTUNE SILICONE VACUUM SUCTION, MODEL #1300, a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on February 12, 2003, 303 days after receiving the submission on April 15, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.

Submission Details

510(k) Number K021193 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2002
Decision Date February 12, 2003
Days to Decision 303 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HDB — Extractor, Vacuum, Fetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4340

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