MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA


Device Classification Name

endoscope and/or accessories

510(k) Number K022270
Device Name MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Codes
FAL   FCG   FEH   FWF   GCJ  
GEI   HIF   ITX   IYO   LFL  
Date Received 07/15/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No