ERCO-VAC

Device, External Penile Rigidity

ERCONS, INC.

The following data is part of a premarket notification filed by Ercons, Inc. with the FDA for Erco-vac.

Pre-market Notification Details

Device IDK972537
510k NumberK972537
Device Name:ERCO-VAC
ClassificationDevice, External Penile Rigidity
Applicant ERCONS, INC. 66 OVERLOOK TERRACE, SUITE 2E New York,  NY  10040
ContactYakov Altshuler
CorrespondentYakov Altshuler
ERCONS, INC. 66 OVERLOOK TERRACE, SUITE 2E New York,  NY  10040
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-08
Decision Date1997-11-03
Summary:summary

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