FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUTEK PERIODONTAL PROBE
K Number: K880827
·
Decision Apr 12, 1988
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
8
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- ACCUTEK PERIODONTAL PROBE
- K Number
- K880827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sweet Micro Systems, Inc.
- Date Received
- March 1, 1988
- Decision Date
- April 12, 1988
- Product Code
- EIX
- 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 |
|---|---|---|---|
| EIX | Probe, Periodontic | FDA class 1 | Dental |
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