THD DISPOSABLE ANOSCOPE/PROCTOSCOPE


Device Classification Name

anoscope and accessories

510(k) Number K080132
Device Name THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
Applicant
THD SPA
via calindri 50
s. lazzaro di savena, bologna, 

IT

40068

Applicant Contact guido bonapace
Correspondent
THD SPA
via calindri 50
s. lazzaro di savena, bologna, 

IT

40068

Correspodent Contact guido bonapace
Regulation Number 876.1500
Classification Product Code
FER  
Subsequent Product Code
GCF  
Date Received 01/18/2008
Decision Date 04/09/2008
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