MENTOR INJECTION PORT DETECTOR (IPD)

Expander, Skin, Inflatable

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Injection Port Detector (ipd).

Pre-market Notification Details

Device IDK963066
510k NumberK963066
Device Name:MENTOR INJECTION PORT DETECTOR (IPD)
ClassificationExpander, Skin, Inflatable
Applicant MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
ContactRonald F Lagerquist
CorrespondentRonald F Lagerquist
MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-07
Decision Date1996-09-27
Summary:summary

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