G-SPERM, MODEL 10032


Device Classification Name

media, reproductive

510(k) Number K022247
Device Name G-SPERM, MODEL 10032
Original Applicant
VITROLIFE SWEDEN AB
1800 massachusetts avenue nw
washington, 
DC 
20036 -1800

Original Contact gary l yingling
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 07/12/2002
Decision Date 09/06/2002
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