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FDA 510(k), K013280, STERILOX LIQUID CHEMICAL STERILANT SYSTEM
FDA 510(k), K013280, STERILOX LIQUID CHEMICAL STERILANT SYSTEM
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510(K) Number: K013280
Device Name: STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Manufacturer: HOWARD MANN
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: KXA
Date Received: 10/02/2001
Decision Date: 09/18/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Manufacturer: HOWARD MANN
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: KXA
Date Received: 10/02/2001
Decision Date: 09/18/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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