510(k) K913383

OXYGEN MASKS 81420, 81421, 81471 & 81461 by Specialty Packaging Producs, Inc. — Product Code BYG

K913383 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "OXYGEN MASKS 81420, 81421, 81471 & 81461". The FDA issued a decision of Substantially Equivalent on October 18, 1991. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.