FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBLIMINATOR
K Number: K961457
·
Decision Jul 18, 1996
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
3
Review Days
93
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Basic Information
- Device Name
- SUBLIMINATOR
- K Number
- K961457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healex Products, Inc.
- Date Received
- April 16, 1996
- Decision Date
- July 18, 1996
- 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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