SPERMCHECK VASECTOMY

Semen Analysis Device

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Spermcheck Vasectomy.

Pre-market Notification Details

Device IDK073039
510k NumberK073039
Device Name:SPERMCHECK VASECTOMY
ClassificationSemen Analysis Device
Applicant PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
ContactKyung-ah Kim
CorrespondentKyung-ah Kim
PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-29
Decision Date2008-01-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.