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Southern California Medical Device Maker Dallen Medical Files for FDA Clearance


9/25/2012 7:32:09 AM

SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Dallen Medical of San Clemente has filed its FDA 510(k) application for the Compressyn™ staple for small bone fixation, specifically in foot, ankle, and hand applications. With the company’s Compressyn™ band for sternal closure already FDA cleared, this application is part of the company’s plan to expand its Compressyn family of products.

“We are very pleased to get this submission in and are excited about the potential of our Compressyn™ technology to improve patient outcomes and thereby reduce costs to the healthcare system,” Dallen Medical president and CEO, David H. Mills said. “All of our investors are pleased with this milestone and the future opportunities for the Compressyn technology.”

Dallen Medical's patented Compressyn technology offers significant improvement over existing products by delivering superior fixation with compression in sternal closure, small bone, and sports med applications. This should result in better patient outcomes, resulting in cost savings and reductions in length of stay.

For more information, visit www.dallenmedical.com

Contact:

Dallen Medical

David H. Mills, President & CEO

(949) 218-0030



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