FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K Number: K103745
·
Decision Jul 20, 2011
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
3
Review Days
209
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Basic Information
- Device Name
- BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
- K Number
- K103745
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Glaxosmithkline Consumer Healthcare (Gskch)
- Date Received
- December 23, 2010
- Decision Date
- July 20, 2011
- Product Code
- LFD
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
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