FORTUNE SILICONE VACUUM SUCTION, MODEL #1300


Device Classification Name

extractor, vacuum, fetal

510(k) Number K021193
Device Name FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
Original Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
12-9, lin 5, mao-chang village
san-chih hsiang
taipei hsien, 

TW

252

Original Contact taipei hsien
Regulation Number 884.4340
Classification Product Code
HDB  
Date Received 04/15/2002
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