FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-Z JECTOR
K Number: K830042
·
Decision Jan 26, 1983
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
6
Review Days
19
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Basic Information
- Device Name
- E-Z JECTOR
- K Number
- K830042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Innovators, Inc.
- Date Received
- January 7, 1983
- Decision Date
- January 26, 1983
- 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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ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
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Other Clearances by Innovators, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921355 | WINGMASTER | Sep 25, 1992 | Substantially Equivalent |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Sep 25, 1992 | Substantially Equivalent |
| K921406 | SILICONT BUR BLOCK | Apr 28, 1992 | Substantially Equivalent |
| K844351 | OPTI-LITE | Dec 21, 1984 | Substantially Equivalent |
| K790984 | KLIP-LITE | Oct 22, 1979 | Substantially Equivalent |