ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K023630
Device Name ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
Original Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
3200 lakeside dr.
santa clara, 
CA 
95054

Original Contact ron allen
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 10/28/2002
Decision Date 02/20/2003
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