510(k) K894779

LIFECARE NASAL MASK KIT CAT. NO. 06-800 by Lifecare Services, Inc. — Product Code BYE

K894779 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "LIFECARE NASAL MASK KIT CAT. NO. 06-800". The FDA issued a decision of Substantially Equivalent on January 12, 1990. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.