
Tecnol New Jersey Wound Care, Inc.
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HIGH FILTRATION ISO-MASK is an FDA 510(k)-cleared medical device (K831148) manufactured by Tecnol New Jersey Wound Care, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 1984. Regulation: 8.