MONTG. LARYNGEAL KEEL

Prosthesis, Larynx (stents And Keels)

BOSTON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montg. Laryngeal Keel.

Pre-market Notification Details

Device IDK842800
510k NumberK842800
Device Name:MONTG. LARYNGEAL KEEL
ClassificationProsthesis, Larynx (stents And Keels)
Applicant BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
ContactUnknown Unknown
CorrespondentUnknown Unknown
BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
Product CodeFWN  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-17
Decision Date1984-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EBES3230600 K842800 000
EBES3230500 K842800 000
EBES3230400 K842800 000
34063107100537 K842800 000
34063107100513 K842800 000
34063107100490 K842800 000

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