KII TROCAR SYSTEM


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K072674
Device Name KII TROCAR SYSTEM
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 avenida empresa
rancho santa margarita, 
CA 
92688

Applicant Contact frans vandenbroek
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/21/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls