Data / Medical devices / Taiwan / Master & Frank Ent. Co., Ltd.
Master & Frank Ent. Co., Ltd.: FDA-registered device maker in Taipei, Taiwan, 3 510(k) clearances
Master & Frank Ent. Co., Ltd. is registered with the FDA (registration 9616876) in Taipei, Taiwan. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 4, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616876
- FEI number
- 1000346129
- Address
- 19 F., No. 57, Sec. 2, Tun Hwa S. Road, Taipei, Taiwan, 106
- Owner or operator
- MASTER & FRANK ENT. CO., LTD. (9043426)
- Roles
- Complaint file establishment
- First device listed
- March 21, 2008
- Registered through
- 2026
- Brand names listed
- DRAPE, Gown, Particulate Respirator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Complaint file establishment | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2018 | K172963 | Master-Frank N95 Particulate Respirator | MSH | Substantially Equivalent | Master & Frank Enterprise Co., Ltd. | accessdata.fda.gov |
| May 3, 2002 | K020393 | MASTER & FRANK SURGICAL DRAPES (STERILE) | KKX | Substantially Equivalent | Master & Frank Enterprses Co., Ltd. | accessdata.fda.gov |
| December 7, 2001 | K012186 | MASTER & FRANK SURGICAL GOWNS (STERILE) | FYA | Substantially Equivalent | Master & Frank Ent. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of Respirator, Surgical
Updated April 4, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.