BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216


Device Classification Name

media, reproductive

510(k) Number K080172
Device Name BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
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 01/24/2008
Decision Date 12/18/2008
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