REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES


Device Classification Name

insufflator, laparoscopic

510(k) Number K072753
Device Name REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
Applicant
RG MEDICAL USA
468 craighead st.
nashville, 
TN 
37204

Applicant Contact winfried reich
Correspondent
RG MEDICAL USA
468 craighead st.
nashville, 
TN 
37204

Correspodent Contact winfried reich
Regulation Number 884.1730
Classification Product Code
HIF  
Subsequent Product Codes
EYN   FMT   FPB   GCJ   JOK  
NGY  
Date Received 09/27/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No