SINGLE STEP MEDIUM


Device Classification Name

media, reproductive

510(k) Number K072609
Device Name SINGLE STEP MEDIUM
Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 daimler st
santa ana, 
CA 
92705

Applicant Contact wendell lee
Correspondent
IRVINE SCIENTIFIC SALES CO., INC.
2511 daimler st
santa ana, 
CA 
92705

Correspodent Contact wendell lee
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 09/17/2007
Decision Date 02/12/2008
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

Yes