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Haag-Streit Holding AG
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OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER is an FDA 510(k)-cleared medical device (K030393) manufactured by Haag-Streit Holding AG. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2003. Regulation: 8.