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Found 2 results

510(k) Data Aggregation

K Number

Device Name

DIOBEAM 830

Manufacturer

SOFT-CORE TEXAS, INC.

Date Cleared

2003-09-16

(126 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

SOFT-CORE TEXAS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

The DioBeam 830™ is for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome

Device Description

Not Found

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K Number

Device Name

ZAP DUAL CURING LIGHT

Manufacturer

SOFT-CORE TEXAS, INC.

Date Cleared

2000-11-28

(64 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

SOFT-CORE TEXAS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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