510(k) K971597

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) by Coloplast Corp. — Product Code NAE

K971597 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)". The FDA issued a decision of Substantially Equivalent on July 29, 1997. The device falls under product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), a Class I device regulated under 21 CFR 878.4022. Coloplast Corp. has at least 10 other 510(k) clearances on record.