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.
Device ID | K021193 |
510k Number | K021193 |
Device Name: | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 |
Classification | Extractor, Vacuum, Fetal |
Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
Contact | Taipei Hsien |
Correspondent | Taipei Hsien FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
Product Code | HDB |
CFR Regulation Number | 884.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-15 |
Decision Date | 2003-02-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04711182604004 | K021193 | 000 |
04710961930013 | K021193 | 000 |
04710961930006 | K021193 | 000 |