FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHILLIT
K Number: K011666
·
Decision Aug 6, 2001
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
1
Review Days
68
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Basic Information
- Device Name
- CHILLIT
- K Number
- K011666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1720
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heatshield, Inc.
- Date Received
- May 30, 2001
- Decision Date
- August 6, 2001
- 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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