FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAROJECT ANESTHETIC SYRINGE
K Number: K904279
·
Decision Dec 7, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
10
Applicant Total
2
Review Days
81
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Basic Information
- Device Name
- PAROJECT ANESTHETIC SYRINGE
- K Number
- K904279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ronvig Instruments, Ltd.
- Date Received
- September 17, 1990
- Decision Date
- December 7, 1990
- Product Code
- EGM
- 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 |
|---|---|---|---|
| EGM | Injector, Jet, Mechanical-Powered | FDA class 2 | Dental |
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Other Clearances by Ronvig Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Oct 13, 2000 | Substantially Equivalent |