FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSIMATIC 500SE
K Number: K950239
·
Decision Jun 6, 1995
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
18
Applicant Total
53
Review Days
137
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Basic Information
- Device Name
- SENSIMATIC 500SE
- K Number
- K950239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Parkell, Inc.
- Date Received
- January 20, 1995
- Decision Date
- June 6, 1995
- Product Code
- EKZ
- 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 |
|---|---|---|---|
| EKZ | Unit, Electrosurgical, And Accessories, Dental | FDA class 2 | Dental |
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