SPEEDICATH COMPACT


Device Classification Name

catheter, urethral

510(k) Number K072808
Device Name SPEEDICATH COMPACT
Applicant
COLOPLAST CORP.
1601 west river n
minneapolis, 
MN 
55411

Applicant Contact rebeka stoltman
Correspondent
COLOPLAST CORP.
1601 west river n
minneapolis, 
MN 
55411

Correspodent Contact rebeka stoltman
Regulation Number 876.5130
Classification Product Code
GBM  
Date Received 10/01/2007
Decision Date 11/09/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No