ISM1+, IMS2+, AND UTM+


Device Classification Name

media, reproductive

510(k) Number K030490
Device Name ISM1+, IMS2+, AND UTM+
Applicant
MEDICULT A/S
p.o. box 262069
san diego, 
CA 
92196 -2069

Applicant Contact ronald g leonardi
Correspondent
MEDICULT A/S
p.o. box 262069
san diego, 
CA 
92196 -2069

Correspodent Contact ronald g leonardi
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 02/14/2003
Decision Date 08/20/2003
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