BWP — Shoe And Shoe Cover, Conductive Class I

FDA Device Classification

FDA product code BWP covers "Shoe And Shoe Cover, Conductive", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BWP
Device Class
Class I
Regulation Number
878.4040
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K880384kimberly-clarkKIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOTJune 23, 1988
K831952sudreca surgical dressingsSURGICAL APPAREL SHOE COVERSJuly 12, 1983
K812105anagoANOGO DISPOSABLE SHOE COVERSeptember 11, 1981