FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAPPER
K Number: K904527
·
Decision Dec 21, 1990
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
2
Review Days
80
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Basic Information
- Device Name
- KAPPER
- K Number
- K904527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Senair-Mot
- Date Received
- October 2, 1990
- Decision Date
- December 21, 1990
- 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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Other Clearances by Senair-Mot
| K Number | Device Name | ||
|---|---|---|---|
| K843406 | CHEW-DENT | Dec 11, 1984 | Substantially Equivalent |