510(k) K971100

ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR by Atrion Medical Products, Inc. — Product Code EIA

K971100 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.