FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
K Number: K181134
·
Decision Jul 13, 2018
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
48
Applicant Total
1
Review Days
74
Basic Information
- Device Name
- GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
- K Number
- K181134
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunstar Americas Inc
- Date Received
- April 30, 2018
- Decision Date
- July 13, 2018
- 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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