ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES


Device Classification Name

pump, air, non-manual, for endoscope

510(k) Number K103696
Device Name ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
Applicant
ERBE USA, INC.
2225 northwest pkwy.
marietta, 
GA 
30067

Applicant Contact john tartal
Correspondent
ERBE USA, INC.
2225 northwest pkwy.
marietta, 
GA 
30067

Correspodent Contact john tartal
Regulation Number 876.1500
Classification Product Code
FEQ  
Date Received 12/17/2010
Decision Date 03/22/2011
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