FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENTLE FLOSS
K Number: K792493
·
Decision Dec 13, 1979
Classifications
1
FEI Numbers
352
Registration Numbers
353
Same Product Code
61
Applicant Total
1
Review Days
9
Basic Information
- Device Name
- GENTLE FLOSS
- K Number
- K792493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- PAUL E. JAFFE, D.M.D.
- Date Received
- December 4, 1979
- Decision Date
- December 13, 1979
- 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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