NANMA VACUUM PUMP

Device, External Penile Rigidity

NANMA MFG CO., LTD.

The following data is part of a premarket notification filed by Nanma Mfg Co., Ltd. with the FDA for Nanma Vacuum Pump.

Pre-market Notification Details

Device IDK993909
510k NumberK993909
Device Name:NANMA VACUUM PUMP
ClassificationDevice, External Penile Rigidity
Applicant NANMA MFG CO., LTD. P.O. BOX 4341 Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
NANMA MFG CO., LTD. P.O. BOX 4341 Crofton,  MD  21114
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-17
Decision Date2000-07-19

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