INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K023344
Device Name INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
Original Applicant
BOWEL MANAGEMENT SYSTEMS, LLC
1886 south 14th st.
suite 6
fernandina beach, 
FL 
32034

Original Contact chad a coberly
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 10/07/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No