FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE

K Number: K842788 · Decision Sep 11, 1984
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
2
Review Days
50

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Basic Information

Device Name
DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE
K Number
K842788
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5070
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Brimms, Inc.
Date Received
July 23, 1984
Decision Date
September 11, 1984
Product Code
JXL
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

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

Product Code Device Name
JXL Block, Bite

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Other Clearances by Brimms, Inc.

K Number Device Name
K831344 DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC