FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACETAL
K Number: K022032
·
Decision Aug 29, 2002
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
7
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- ACETAL
- K Number
- K022032
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3285
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inovativ, LLC
- Date Received
- June 21, 2002
- Decision Date
- August 29, 2002
- Product Code
- EHP
- 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 |
|---|---|---|---|
| EHP | Clasp, Preformed | FDA class 1 | Dental |
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