LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K030824
Device Name LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
Applicant
HAKKO MEDICAL CO., LTD.
4545 creek rd.
cincinnati, 
OH 
45242

Applicant Contact elizabeth miller
Correspondent
HAKKO MEDICAL CO., LTD.
4545 creek rd.
cincinnati, 
OH 
45242

Correspodent Contact elizabeth miller
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 03/14/2003
Decision Date 06/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No