510(k) K991788

SALTER LABS PEP DEVICE by Salter Labs — Product Code CAF

K991788 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER LABS PEP DEVICE". The FDA issued a decision of Substantially Equivalent on August 6, 1999. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Salter Labs has at least 10 other 510(k) clearances on record.