ENDOSCOPIC ACCESS DEVICE


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K960232
Device Name ENDOSCOPIC ACCESS DEVICE
Applicant
APPLIED MEDICAL TECHNOLOGIES
6100 west creek rd.
suite 25
independence, 
OH 
44131

Applicant Contact kathy feltrin
Correspondent
APPLIED MEDICAL TECHNOLOGIES
6100 west creek rd.
suite 25
independence, 
OH 
44131

Correspodent Contact kathy feltrin
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 01/17/1996
Decision Date 03/21/1996
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