KSEA MEDI PACK


Device Classification Name

endoscope and/or accessories

510(k) Number K022490
Device Name KSEA MEDI PACK
Original Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe 5th floor
culver city, 
CA 
90230 -7600

Original Contact james a lee
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
FET  
Date Received 07/29/2002
Decision Date 09/29/2003
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