FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

Extractor, Vacuum, Fetal

FORTUNE MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for Fortune Silicone Vacuum Suction, Model #1300.

Pre-market Notification Details

Device IDK021193
510k NumberK021193
Device Name:FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
ClassificationExtractor, Vacuum, Fetal
Applicant FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien,  TW 252
ContactTaipei Hsien
CorrespondentTaipei Hsien
FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien,  TW 252
Product CodeHDB  
CFR Regulation Number884.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-15
Decision Date2003-02-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04711182604004 K021193 000
04710961930013 K021193 000
04710961930006 K021193 000

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