SPEEDICATH COMPACT SET (12/18 FR)


Device Classification Name

catheter, urethral

510(k) Number K121458
Device Name SPEEDICATH COMPACT SET (12/18 FR)
Applicant
COLOPLAST A/S
1601 west river road north
minneapolis, 
MN 
55411

Applicant Contact brian schmidt
Correspondent
COLOPLAST A/S
1601 west river road north
minneapolis, 
MN 
55411

Correspodent Contact brian schmidt
Regulation Number 876.5130
Classification Product Code
GBM  
Date Received 05/16/2012
Decision Date 10/01/2012
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