FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇷 France

NASALCEASE

K Number: K041446 · Decision Jul 1, 2004
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
5
Review Days
30

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Basic Information

Device Name
NASALCEASE
K Number
K041446
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
874.4100
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Les Laboratorires Brothier, S.A.
Date Received
June 1, 2004
Decision Date
July 1, 2004
Product Code
EMX
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EMX Balloon, Epistaxis

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EMX), ordered by most recent decision date.

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Other Clearances by Les Laboratorires Brothier, S.A.

K Number Device Name
K984069 ENTAXIS NASAL PACKING
K922540 WOUND DRESSING
K905314 ALGODERM ALGINATE WOUND DRESSING
K893123 ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES