ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM

Device, External Penile Rigidity

ENDOCARE, INC.

The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System.

Pre-market Notification Details

Device IDK020082
510k NumberK020082
Device Name:ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM
ClassificationDevice, External Penile Rigidity
Applicant ENDOCARE, INC. 6585 CITY WEST PKWY. Eden Prairie,  MN  55344
ContactChris Hadland
CorrespondentChris Hadland
ENDOCARE, INC. 6585 CITY WEST PKWY. Eden Prairie,  MN  55344
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-10
Decision Date2002-02-05
Summary:summary

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