NANMA AJUSTABLE CONSTRICTION RING

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 Ajustable Constriction Ring.

Pre-market Notification Details

Device IDK993908
510k NumberK993908
Device Name:NANMA AJUSTABLE CONSTRICTION RING
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 Date2000-01-31

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