SPERMASSIST


Device Classification Name

media, reproductive

510(k) Number K022443
Device Name SPERMASSIST
Original Applicant
NIDACON INTERNATIONAL AB
p.o. box 7007
deerfield, 
IL 
60015

Original Contact daniel kamm
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 07/25/2002
Decision Date 08/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No