ERCO-VAC -C

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 -c.

Pre-market Notification Details

Device IDK990006
510k NumberK990006
Device Name:ERCO-VAC -C
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 Received1999-01-04
Decision Date1999-02-24
Summary:summary

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