
Tecnol Medical Products, Inc.
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PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL is an FDA 510(k)-cleared medical device (K974068) manufactured by Tecnol Medical Products, 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 December 21, 1997. Regulation: 8.