PURESPERM 40 AND PURESPERM 80


information about

Device Classification Name

media, reproductive

510(k) Number K002623
Device Name PURESPERM 40 AND PURESPERM 80
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 08/23/2000
Decision Date 11/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No