FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K Number: K193336
·
Decision May 27, 2020
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
40
Applicant Total
3
Review Days
177
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Basic Information
- Device Name
- Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
- K Number
- K193336
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synedgen, Inc.
- Date Received
- December 2, 2019
- Decision Date
- May 27, 2020
- Product Code
- OLR
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OLR | Oral Wound Dressing | FDA unclassified | Unknown |
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