510(k) K902298

ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS by Rondex Products, Inc. — Product Code BSJ

K902298 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.