FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMAC WIRES
K Number: K910090
·
Decision Jul 25, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
2
Review Days
197
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Basic Information
- Device Name
- DIMAC WIRES
- K Number
- K910090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4600
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Instrumentations Unltd.
- Date Received
- January 9, 1991
- Decision Date
- July 25, 1991
- Product Code
- DYX
- 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 |
|---|---|---|---|
| DYX | Lock, Wire, And Ligature, Intraoral | FDA class 2 | Dental |
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Other Clearances by Instrumentations Unltd.
| K Number | Device Name | ||
|---|---|---|---|
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Feb 13, 1987 | Substantially Equivalent |