FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPACELINE FEEL 21
K Number: K953865
·
Decision Mar 20, 1996
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
52
Review Days
216
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Basic Information
- Device Name
- SPACELINE FEEL 21
- K Number
- K953865
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J. Morita USA, Inc.
- Date Received
- August 17, 1995
- Decision Date
- March 20, 1996
- Product Code
- EFA
- 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | FDA class 1 | Dental |
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