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Found 3 results

510(k) Data Aggregation

K Number

Device Name

IMNI HOT PACKS

Manufacturer

OMNI THERM, INC.

Date Cleared

1996-09-04

(257 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OMNI THERM, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

OMNI COLD GEL PACKS

Manufacturer

OMNI THERM, INC.

Date Cleared

1996-09-04

(163 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OMNI THERM, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

K Number

Device Name

OMNI COLD GEL PACKS

Manufacturer

OMNI THERM, INC.

Date Cleared

1996-02-13

(112 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OMNI THERM, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

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