FORTUNE SILICONE VACUUM SUCTION, MODEL #1300— 510(k) K021193

Clearance details

Applicant

Fortune Medical Instrument Corp.

Product code

Code HDB

Device class

Class 2

Regulation

21 CFR 884.4340

Advisory panel

Obstetrics/Gynecology

Date received

2002-04-15

Decision date

2003-02-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taipei Hsien, TW

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Death

7

Total

7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →