PURITAN FOAM TIP SWAB MODEL 2197

PURITAN FOAM TIP SWAB MODEL 2197 is an FDA 510(k)-cleared medical device (K961934) manufactured by Hardwood Products Co., LP. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 1996. Regulation: 8.