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Found 2 results

510(k) Data Aggregation

K Number

Device Name

QS DELIVERY SYSTEM

Manufacturer

SUB-Q, INC.

Date Cleared

1999-08-23

(132 days)

Product Code

KYZ

Regulation Number

880.6960

Why did this record match?

Applicant Name (Manufacturer) :

SUB-Q, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The QS Delivery System is intended for the delivery of hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

Device Description

Not Found

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K Number

Device Name

IRRIGATION SYRINGE KIT

Manufacturer

SUB-Q, INC.

Date Cleared

1998-11-06

(116 days)

Product Code

KYZ

Regulation Number

880.6960

Why did this record match?

Applicant Name (Manufacturer) :

SUB-Q, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

Device Description

Irrigation Syringe Kit

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