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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K021193
Device Name FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
Applicant
Fortune Medical Instrument Corp.
12-9, Lin 5, Mao-Chang Village
San-Chih Hsiang
Taipei Hsien,  TW 252
Applicant Contact TAIPEI HSIEN
Correspondent
Fortune Medical Instrument Corp.
12-9, Lin 5, Mao-Chang Village
San-Chih Hsiang
Taipei Hsien,  TW 252
Correspondent Contact TAIPEI HSIEN
Regulation Number884.4340
Classification Product Code
HDB  
Date Received04/15/2002
Decision Date 02/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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