510(k) K854595

P.A. MEDICAL VAGINAL IRRIGATION SET #1130 by Pa Medical Corp. — Product Code HED

K854595 is an FDA 510(k) premarket notification submitted by Pa Medical Corp. for the device "P.A. MEDICAL VAGINAL IRRIGATION SET #1130". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code HED (Douche Apparatus, Vaginal, Therapeutic), a Class I device regulated under 21 CFR 884.5900. Pa Medical Corp. has at least 4 other 510(k) clearances on record.