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Found 9 results

510(k) Data Aggregation

K Number

Device Name

RAND NASAL PACKING

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-10-18

(23 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

SPIRIT RIDGE SILICONE CARVING BLOCK

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-22

(65 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

DURALASTIC SHEETING II

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-16

(59 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-16

(148 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document describes toxicology tests, eye irritation tests, and cytotoxicity tests for a contact lens material, along with design specifications and a comparison to a predicate device. However, it does not provide details like a table of acceptance criteria vs. reported performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, details of MRMC or standalone studies, or ground truth establishment for training and test sets.

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K Number

Device Name

MEDIAL MALAR IMPLANT

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

THE MAGNUM CHIN IMPLANT

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(29 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-03-28

(127 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RAND SCIENTIFIC CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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