SPERMGRAD, MODELS 10022/10063


Device Classification Name

media, reproductive

510(k) Number K023403
Device Name SPERMGRAD, MODELS 10022/10063
Original Applicant
VITROLIFE SWEDEN AB
molndalsvagen 30
gothenburg, 

SE

se-412 63

Original Contact nina arvidsson
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 10/10/2002
Decision Date 12/13/2002
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