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Found 21 results

510(k) Data Aggregation

K Number

Device Name

CPR TRACHEOTOMY CARE TRAY

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-08-27

(224 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K020457,K991806

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Device Name

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-05-23

(128 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Device Name

CPR C-SECTION DELIVERY PACK

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-05-23

(128 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

CPR SUCTION CATHETER KIT

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-15

(90 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Device Name

CPR DRESSING CHANGE TRAY

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-12

(87 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

CPR ORTHO HAND PACK

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-12

(87 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

CPR TOTAL HIP PACK

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-12

(87 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Device Name

CPR TOTAL KNEE PACK

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-12

(87 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Device Name

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-04

(79 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

CPR FOLEY CAHTETER KIT

Manufacturer

CUSTOM PACK RELIABILITY

Date Cleared

1996-04-01

(76 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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