FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPS
K Number: K932012
·
Decision Nov 3, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
1
Review Days
194
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Basic Information
- Device Name
- CAPS
- K Number
- K932012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chemichl, Inc.
- Date Received
- April 23, 1993
- Decision Date
- November 3, 1993
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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