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FDA 510(k), K091722, COAXIAL APPLICATOR SYSTEM
FDA 510(k), K091722, COAXIAL APPLICATOR SYSTEM
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510(K) Number: K091722
Device Name: COAXIAL APPLICATOR SYSTEM
Manufacturer: ELIZABETH WRAY
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: KXA
Date Received: 06/11/2009
Decision Date: 03/12/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: COAXIAL APPLICATOR SYSTEM
Manufacturer: ELIZABETH WRAY
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: KXA
Date Received: 06/11/2009
Decision Date: 03/12/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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