POS-T-VAC (AVP-1000)

Device, External Penile Rigidity

POS-T-VAC, INC.

The following data is part of a premarket notification filed by Pos-t-vac, Inc. with the FDA for Pos-t-vac (avp-1000).

Pre-market Notification Details

Device IDK983245
510k NumberK983245
Device Name:POS-T-VAC (AVP-1000)
ClassificationDevice, External Penile Rigidity
Applicant POS-T-VAC, INC. 1701 NORTH 14TH AVE. P.O. BOX 1436 Dodge City,  KS  67801
ContactEd Stewart Jr
CorrespondentEd Stewart Jr
POS-T-VAC, INC. 1701 NORTH 14TH AVE. P.O. BOX 1436 Dodge City,  KS  67801
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-16
Decision Date1998-11-02

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