DOYLE COMBO NASAL AIRWAY SPLINT

Splint, Intranasal Septal

BOSTON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Doyle Combo Nasal Airway Splint.

Pre-market Notification Details

Device IDK972151
510k NumberK972151
Device Name:DOYLE COMBO NASAL AIRWAY SPLINT
ClassificationSplint, Intranasal Septal
Applicant BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
ContactStuart K Montgomery
CorrespondentStuart K Montgomery
BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-09
Decision Date1997-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EBES602020 K972151 000

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