FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K Number: K173237
·
Decision Mar 19, 2018
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
1
Review Days
165
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Basic Information
- Device Name
- Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
- K Number
- K173237
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syendgen, Inc.
- Date Received
- October 5, 2017
- Decision Date
- March 19, 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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