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Retinapharma Technologies, Inc.
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TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) is an FDA 510(k)-cleared medical device (K042099) manufactured by Retinapharma Technologies, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2004. Regulation: 8.