READYSWIM


Device Classification Name

media, reproductive

510(k) Number K011346
Device Name READYSWIM
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 05/02/2001
Decision Date 06/28/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No