510(k) K920747

PESSARY FLEXIBLE SILICONE DONUT RING by Bioteque America, Inc. — Product Code HHW

K920747 is an FDA 510(k) premarket notification submitted by Bioteque America, Inc. for the device "PESSARY FLEXIBLE SILICONE DONUT RING". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Bioteque America, Inc. has at least 9 other 510(k) clearances on record.