BA-CPAS

Prosthesis, Nose, Internal

NOBELPHARMA USA, INC.

The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Ba-cpas.

Pre-market Notification Details

Device IDK945154
510k NumberK945154
Device Name:BA-CPAS
ClassificationProsthesis, Nose, Internal
Applicant NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont,  IL  60559
ContactMary Edwards
CorrespondentMary Edwards
NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont,  IL  60559
Product CodeFZE  
CFR Regulation Number878.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-21
Decision Date1995-01-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09321502021753 K945154 000
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09321502021685 K945154 000
09321502021678 K945154 000
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09321502014397 K945154 000
09321502014380 K945154 000
09321502014373 K945154 000
09321502021715 K945154 000
09321502021722 K945154 000
09321502014465 K945154 000
09321502063425 K945154 000
09321502063418 K945154 000
09321502063401 K945154 000
09321502063395 K945154 000
09321502063388 K945154 000
09321502063371 K945154 000
09321502021739 K945154 000
09321502014366 K945154 000

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