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FDA 510(k), K103745, BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
FDA 510(k), K103745, BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
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510(K) Number: K103745
Device Name: BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
Manufacturer: WENDY A MCMANUS
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: 12/23/2010
Date Received: 07/20/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
Manufacturer: WENDY A MCMANUS
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: 12/23/2010
Date Received: 07/20/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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