MEDI-CULT SPERM PREPARATION – MEDIUM;


Device Classification Name

media, reproductive

510(k) Number K991332
Device Name MEDI-CULT SPERM PREPARATION – MEDIUM;
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 04/19/1999
Decision Date 05/04/2000
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