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Date Cleared

2009-06-05

(32 days)

Product Code

Regulation Number

Intended Use

The COVIDIEN Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

Device Description

The COVIDIEN Extended Tip Applicator is a single-use, disposable applicator intended for the simultaneous delivery of two non-homogenous solutions onto a surgical site. The COVIDIEN Extended Tip Applicator provides two (2) female luer fittings for connection to standard syringes containing two non-homogenous solutions. The shaft of the Extended Tip Applicator maintains two separate and independent lumens, which keep the two solutions separate and prevent premature mixing. The Extended Tip Applicator shaft is bendable up to 60 degrees to facilitate access to confined spaces at the surgical site.

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K Number

K072790

Device Name

CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008

Manufacturer

Date Cleared

2008-01-11

(102 days)

Product Code

Regulation Number

Intended Use

The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.

Device Description

The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.

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K Number

K070814

Device Name

MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP

Manufacturer

Date Cleared

2007-05-30

(65 days)

Product Code

Regulation Number

Intended Use

The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Device Description

The Confluent Surgical MicroMyst Applicator will be configured using the following components: Applicator Air line with Filter Air Source

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K Number

K061183

Device Name

CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093

Manufacturer

Date Cleared

2006-06-01

(34 days)

Product Code

Regulation Number

Intended Use

The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Device Description

The Confluent Surgical Dual Liquid Applicator will be configured using the following components: Y-Connector, Three Spray Tips; the Spray Tip consists of a polycarbonate Spray Tip, and a polycarbonate or nylon orifice cup, Plunger Cap.

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K Number

K050998

Device Name

CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063

Manufacturer

Date Cleared

2005-06-15

(56 days)

Product Code

Regulation Number

Intended Use

The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.

Device Description

The MicroMyst Applicator and Air Pump will be configured using the following components: Applicator with flexible tip Air line with filter Air Pump

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K Number

K042588

Device Name

CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093

Manufacturer

Date Cleared

2004-12-09

(78 days)

Product Code

Regulation Number