K Number
K963558
Device Name
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
Date Cleared
1996-12-04

(90 days)

Product Code
Regulation Number
878.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
More Information

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§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.

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