FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOSPIK
K Number: K853767
·
Decision Dec 2, 1985
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- FLOSPIK
- K Number
- K853767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Medelco , Ltd.
- Date Received
- September 9, 1985
- Decision Date
- December 2, 1985
- 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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