510(k) K885323

DACOMED EXTERNAL MALE CONTINENCE DEVICE by Dacomed Corp. — Product Code FHA

K885323 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED EXTERNAL MALE CONTINENCE DEVICE". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Dacomed Corp. has at least 10 other 510(k) clearances on record.