FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETY PLUS
K Number: K945843
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
4
Review Days
223
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Basic Information
- Device Name
- SAFETY PLUS
- K Number
- K945843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arent Fox
- Date Received
- November 30, 1994
- Decision Date
- July 11, 1995
- Product Code
- EJI
- 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 |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
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