510(k) K991799

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO by Davol Inc., Sub. C. R. Bard, Inc. — Product Code HIG

K991799 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.