510(k) K972705

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC by Sage Products, Inc. — Product Code FMI

K972705 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sage Products, Inc. has at least 10 other 510(k) clearances on record.