
Candela Laser Corp.
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CANDELA SHEATH SETS is an FDA 510(k)-cleared medical device (K950634) manufactured by Candela Laser Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 1995. Regulation: 8.

ADC
SKU DX606933

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