BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540


Device Classification Name

microtools, assisted reproduction (pipettes)

510(k) Number K022643
Device Name BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
Original Applicant
SWEMED LAB INTERNATIONAL AB
555 13th st. n.w.
washington, 
DC 
20004

Original Contact howard m holstein
Regulation Number 884.6130
Classification Product Code
MQH  
Date Received 08/08/2002
Decision Date 11/05/2002
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