510(k) K901301

STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL by Automatic Liquid Packaging, Inc. — Product Code CAF

K901301 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL". The FDA issued a decision of Substantially Equivalent on May 31, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.