EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED


Device Classification Name

media, reproductive

510(k) Number K080473
Device Name EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
Applicant
MEDICULT A/S
9915 cam.chirimolla
san diego, 
CA 
92131

Applicant Contact ronald g leonardi
Correspondent
MEDICULT A/S
9915 cam.chirimolla
san diego, 
CA 
92131

Correspodent Contact ronald g leonardi
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 02/21/2008
Decision Date 09/03/2008
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