FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

NASAL SEPTAL BUTTON

K Number: K850492 · Decision Mar 7, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
8
Review Days
27

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Basic Information

Device Name
NASAL SEPTAL BUTTON
K Number
K850492
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Santa Barbara Medco, Inc.
Date Received
February 8, 1985
Decision Date
March 7, 1985
Product Code
LFB
Advisory Committee
Unknown
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
LFB Button, Nasal Septal

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K812069 BORES* DEPTH GAUGE
K812071 RK IV SURGICAL BLADES
K812070 BORES* ADJUSTABLE BLADE HOLDER
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