510(k) K952689

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK by Owens-Brigam Medical Co. — Product Code BSJ

K952689 is an FDA 510(k) premarket notification submitted by Owens-Brigam Medical Co. for the device "BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Owens-Brigam Medical Co. has at least 1 other 510(k) clearance on record.