FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESIL
K Number: K840548
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
30
Review Days
69
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Basic Information
- Device Name
- RESIL
- K Number
- K840548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- February 8, 1984
- Decision Date
- April 17, 1984
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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