American Fluoroseal Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What American Fluoroseal Corp. makes
American Fluoroseal Corp. manufactures sterile barrier packaging solutions, including KAPTON peel pouches and tissue culture bags designed for medical and laboratory use. These products are intended to protect sensitive materials from contamination during storage and transport.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the 510(k) registry. The products are regulated under US FDA requirements and comply with applicable standards for sterile barrier systems.
Catalogue
Kapton Peel Pouch Ref K933228
Regimes: 510(k) Registry: 510(k)Tissue Culture Bag Ref K870865
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Fluoroseal Corp. have in the registry?
The registry currently lists 2 devices for American Fluoroseal Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Fluoroseal Corp.'s devices?
Among its 2 most recently registered devices, American Fluoroseal Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do American Fluoroseal Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for American Fluoroseal Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from American Fluoroseal Corp. in the registry?
The most recently registered devices listed for American Fluoroseal Corp. include KAPTON PEEL POUCH and TISSUE CULTURE BAG.