MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22


Device Classification Name

endoscopic contamination prevention sheath

510(k) Number K080550
Device Name MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
Applicant
MINOS MEDICAL
15560-c rockfield blvd
irvine, 
CA 
92618

Applicant Contact tom colonna
Correspondent
MINOS MEDICAL
15560-c rockfield blvd
irvine, 
CA 
92618

Correspodent Contact tom colonna
Regulation Number 876.1500
Classification Product Code
ODB  
Date Received 02/28/2008
Decision Date 06/10/2008
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