
9th Wave, Inc.
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9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS is an FDA 510(k)-cleared medical device (K963620) manufactured by 9th Wave, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 1997. Regulation: 8.

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