Frankenman International Ltd Secures FDA Clearance For Its Entire CHEX Range Of Surgical Staplers

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jun 2009 - 1:00 PDT

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Frankenman International Ltd, the manufacturer and supplier of surgical instruments, announced that its entire CHEX™ range of surgical staplers had been granted FDA approval. This development complements the CE and ISO accreditation it has already acquired. FDA approval endorses Frankenman's commitment to total quality in surgical stapling and wound closure devices, and further validates its position as a trusted alternative supplier in these markets.

Having established itself in Europe and many other international markets, Frankenman International Ltd now plans to expand marketing of the CHEX range into Japan, Australia and Korea by the end of 2009. This will enable more patients and hospitals around the world to benefit from its cost-effective range of surgical instruments.

"We are delighted to have secured FDA registration as this globally recognised quality mark will further strengthen surgeons' confidence in our CHEX range of surgical staplers and establish Frankenman International as a credible player," comments Lee Edwards, President of International Business at Frankenman International Ltd. "With a well established, professional and successful distribution network in place, we are now concentrating on strategic growth by accelerating our internal and external R & D programmes so that we can bring even more innovative instruments to our customers in the coming years."

Source
Frankenman International Ltd.