MEDLINE PNEUMOPERITONEUM NEEDLE


Device Classification Name

insufflator, laparoscopic

510(k) Number K111955
Device Name MEDLINE PNEUMOPERITONEUM NEEDLE
Applicant
MEDLINE, INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Applicant Contact matt clausen
Correspondent
MEDLINE, INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Correspodent Contact matt clausen
Regulation Number 884.1730
Classification Product Code
HIF  
Subsequent Product Codes
FHO   KOG  
Date Received 07/11/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No