SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM


Device Classification Name

labware, assisted reproduction

510(k) Number K112644
Device Name SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
Applicant
LOTUS BIO LTD
461 main street
suite 217
pawtucket, 
RI 
02860

Applicant Contact lori kahler
Correspondent
LOTUS BIO LTD
461 main street
suite 217
pawtucket, 
RI 
02860

Correspodent Contact lori kahler
Regulation Number 884.6160
Classification Product Code
MQK  
Subsequent Product Code
MQG  
Date Received 09/12/2011
Decision Date 12/19/2012
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