ANDREWS INTRODUCER, MODEL ASI01


Device Classification Name

instrument, manual, surgical, general use

510(k) Number K023173
Device Name ANDREWS INTRODUCER, MODEL ASI01
Original Applicant
ANDREWS SURGICAL INNOVATIONS, LTD.
16 grove lawn
malahide
co. dublin, 

IE

Original Contact emmet andrews
Regulation Number 878.4800
Classification Product Code
MDM  
Date Received 09/23/2002
Decision Date 12/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No