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FDA 510(k), K072306, BIOXTRA MOISTURIZING GEL
FDA 510(k), K072306, BIOXTRA MOISTURIZING GEL
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510(K) Number: K072306
Device Name: BIOXTRA MOISTURIZING GEL
Manufacturer: EMALEE MURPHY
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: KXA
Date Received: 08/17/2007
Decision Date: 11/15/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: BIOXTRA MOISTURIZING GEL
Manufacturer: EMALEE MURPHY
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: KXA
Date Received: 08/17/2007
Decision Date: 11/15/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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