San-M Package Co., Ltd.
JapanFDA applicant, unverified FDA FEI 3002809487
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What San-M Package Co., Ltd. makes
San-M Package Co., Ltd. manufactures N95 particulate respirators (Models TN01-11 and TN01-12) and surgical face masks, including variants with ear loops and tie-on designs. These products are intended for respiratory protection and surgical use in healthcare settings.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Surgical Face Masks (Ear Loops And Tie-On) Ref K221534
Regimes: 510(k) Registry: 510(k)Surgical Face Masks (Ear loops and Tie-on) Ref K160269
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002809487
- Address
- 1086-1 OJIRO, Shimada-city Shizuoka
Frequently asked questions
How many devices does San-M Package Co., Ltd. have in the registry?
The registry currently lists 3 devices for San-M Package Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list San-M Package Co., Ltd.'s devices?
Among its 3 most recently registered devices, San-M Package Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do San-M Package Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for San-M Package Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from San-M Package Co., Ltd. in the registry?
The most recently registered devices listed for San-M Package Co., Ltd. include N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 and Surgical Face Masks (Ear Loops And Tie-On).