PNEUMOPERITONEUM INSUFFLATION NEEDLE


Device Classification Name

insufflator, laparoscopic

510(k) Number K021247
Device Name PNEUMOPERITONEUM INSUFFLATION NEEDLE
Original Applicant
MECTRA LABS, INC.
p.o. box 350
bloomfield, 
IN 
47424

Original Contact charles e allgood
Regulation Number 884.1730
Classification Product Code
HIF  
Date Received 04/19/2002
Decision Date 11/08/2002
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