IMPOAID

Device, External Penile Rigidity

IMPOAID, INC.

The following data is part of a premarket notification filed by Impoaid, Inc. with the FDA for Impoaid.

Pre-market Notification Details

Device IDK000730
510k NumberK000730
Device Name:IMPOAID
ClassificationDevice, External Penile Rigidity
Applicant IMPOAID, INC. P.O. BOX 560 Stillwater,  MN  55082
ContactElain Duncan
CorrespondentElain Duncan
IMPOAID, INC. P.O. BOX 560 Stillwater,  MN  55082
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-06
Decision Date2000-10-19

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