FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VUTLER G.U.M. WITH FLUORIDE
K Number: K952091
·
Decision Jun 28, 1995
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- VUTLER G.U.M. WITH FLUORIDE
- K Number
- K952091
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- John O. Butler Co.
- Date Received
- May 3, 1995
- Decision Date
- June 28, 1995
- Product Code
- JES
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| JES | Floss, Dental | FDA class 1 | Dental |
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