AG-PLUS, MODEL 91210

Nebulizer (direct Patient Interface)

MEDEL S.P.A.

The following data is part of a premarket notification filed by Medel S.p.a. with the FDA for Ag-plus, Model 91210.

Pre-market Notification Details

Device IDK060404
510k NumberK060404
Device Name:AG-PLUS, MODEL 91210
ClassificationNebulizer (direct Patient Interface)
Applicant MEDEL S.P.A. 112 CAVISTON WAY Cary,  NC  27519
ContactTerrence O'brien
CorrespondentTerrence O'brien
MEDEL S.P.A. 112 CAVISTON WAY Cary,  NC  27519
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-15
Decision Date2006-06-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00383730004044 K060404 000
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00383730002040 K060404 000
00383730002033 K060404 000
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00383730002002 K060404 000
00383730001999 K060404 000
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00383730002095 K060404 000
00383730002101 K060404 000
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00383730002156 K060404 000
00383730002149 K060404 000
00383730002132 K060404 000
00383730002125 K060404 000
00383730002118 K060404 000
00383730001968 K060404 000

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