CAPHOSOL

Saliva, Artificial

INPHARMA A.S.

The following data is part of a premarket notification filed by Inpharma A.s. with the FDA for Caphosol.

Pre-market Notification Details

Device IDK030802
510k NumberK030802
Device Name:CAPHOSOL
ClassificationSaliva, Artificial
Applicant INPHARMA A.S. 96 WEST MAIN ST. Northborough,  MA  01532
ContactBruce Manning
CorrespondentBruce Manning
INPHARMA A.S. 96 WEST MAIN ST. Northborough,  MA  01532
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-13
Decision Date2003-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060146291576 K030802 000

Trademark Results [CAPHOSOL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPHOSOL
CAPHOSOL
75092944 2487745 Live/Registered
EUSA PHARMA (USA), INC.
1996-04-23

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