FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-MITT (CONDUCTIVE HAND COVER)
K Number: K883804
·
Decision Jul 31, 1989
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
1
Review Days
327
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Basic Information
- Device Name
- E-MITT (CONDUCTIVE HAND COVER)
- K Number
- K883804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1720
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- The Institute For Technology Development
- Date Received
- September 7, 1988
- Decision Date
- July 31, 1989
- Product Code
- EAT
- 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 |
|---|---|---|---|
| EAT | Tester, Pulp | FDA class 2 | Dental |
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