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510(k) Data Aggregation

K Number

Device Name

ACCU-BITE HOME KIT DISCLUDER

Manufacturer

JEROME M. SIMON

Date Cleared

1998-10-07

(208 days)

Product Code

MQC

Regulation Number

N/A

Why did this record match?

Applicant Name (Manufacturer) :

JEROME M. SIMON

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

- An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference. - Prescription device.

Device Description

Not Found

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