510(k) K844765

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN by Laser Spectrum, Inc. — Product Code EWQ

K844765 is an FDA 510(k) premarket notification submitted by Laser Spectrum, Inc. for the device "ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code EWQ (Saw, Surgical, Ent (Electric Or Pneumatic)), a Class I device regulated under 21 CFR 874.4420. Laser Spectrum, Inc. has at least 4 other 510(k) clearances on record.