SAFETY TROCER WITH SPRINGLOADED OBDURATOR


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K960347
Device Name SAFETY TROCER WITH SPRINGLOADED OBDURATOR
Applicant
SPIESS DESIGN, INC.
290 telser rd.
lake zurich, 
IL 
60047

Applicant Contact dieter keppel
Correspondent
SPIESS DESIGN, INC.
290 telser rd.
lake zurich, 
IL 
60047

Correspodent Contact dieter keppel
Regulation Number 884.1720
Classification Product Code
HET  
Date Received 01/25/1996
Decision Date 07/01/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No