FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COREFORM MOLDS
K Number: K801530
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
371
Registration Numbers
371
Same Product Code
15
Applicant Total
37
Review Days
26
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Basic Information
- Device Name
- COREFORM MOLDS
- K Number
- K801530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- July 2, 1980
- Decision Date
- July 28, 1980
- Product Code
- DZN
- 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 |
|---|---|---|---|
| DZN | Instruments, Dental Hand | FDA class 1 | Dental |
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