FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K Number: K002168
·
Decision Oct 13, 2000
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
- K Number
- K002168
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ronvig Instruments, Ltd.
- Date Received
- July 17, 2000
- Decision Date
- October 13, 2000
- 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 Ronvig Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K904279 | PAROJECT ANESTHETIC SYRINGE | Dec 7, 1990 | Substantially Equivalent |