Harken Products, Inc.
Country not established
- Devices
- 1
What Harken Products, Inc. makes
Harken Products, Inc. manufactures the Harken Assure Self-Seal Sterilization Pouch, a sterile barrier pouch designed for medical device sterilization and packaging to maintain sterility during storage and transport.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Harken Assure Self-Seal Sterilization Pouch Ref K945055
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harken Products, Inc. have in the registry?
The registry currently lists 1 device for Harken Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harken Products, Inc.'s devices?
Among its 1 most recently registered device, Harken Products, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Harken Products, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Harken Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Harken Products, Inc. in the registry?
The most recently registered devices listed for Harken Products, Inc. include HARKEN ASSURE SELF-SEAL STERILIZATION POUCH.