SPERMCHECK VASECTOMY


Device Classification Name

counter, differential cell

510(k) Number K073039
Device Name SPERMCHECK VASECTOMY
Applicant
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Applicant Contact kyung-ah kim
Correspondent
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Correspodent Contact kyung-ah kim
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 10/29/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No