FDA.reportPublic FDA data

510(k) K030119

Device
NANMA ADJUSTABLE CONSTRICTION RING
Applicant
Nanma Mfg Co., Ltd.
510(k) number
K030119
Product code
LKY
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-06
Date received
2003-01-13
Regulation
876.5020
Classification name
Device, External Penile Rigidity
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
YOLANDA SMITH
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.2004-08-25
K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.2003-10-03
K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.2003-06-03
K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.2002-12-20
K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.2002-08-22
K020969VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.2002-06-05
K013053MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.2002-05-09
K020154VT-1Pos-T-Vac, Inc.2002-04-04
K020258SUPPORT SLEEVEPos-T-Vac, Inc.2002-04-04
K020082ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEMEndocare, Inc.2002-02-05
K012639SE-300 VACUUM THERAPY SYSTEMVts, Inc.2001-11-09
K012662SE-100 VACUUM ERECTION DEVICEVts, Inc.2001-11-09
K012670BOSS 2000-3 VACUUM ERECTION DEVICEPos-T-Vac, Inc.2001-11-09
K012672BOSS-2000-2 VACUUM ERECTION DEVICEPos-T-Vac, Inc.2001-11-09
K012620SE-200Vts, Inc.2001-11-09