Regulatory Actions
Ascent Healthcare Receives 510(k) Clearance on Alcon MACKOOL Phaco Tips
Published in Medical Letter on the CDC and FDA, June 3rd, 2007
Ascent Healthcare Solutions announced that the U.S. Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess the Alcon(R) MACKOOL phacoemulsification tips. The cleared 510(k) covers all 15 model numbers within the MACKOOL product series. Ascent is the only reprocessor to receive a 510(k) clearance for these devices. This is Ascent's 78th cleared 510(k), the most FDA clearances held by any medical device reprocessing company.
"With the cost of healthcare supplies rising at an ever increasing rate, using devices reprocessed according to FDA guidelines can safely save hospitals and eye surgery centers thousands of dollars each year and reduce the impact...
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