510(k) K911784

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY by North American Sterilization & Packaging Co. — Product Code BTQ

K911784 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.