FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JSB JET SYRINGE
K Number: K834361
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
10
Applicant Total
4
Review Days
130
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Basic Information
- Device Name
- JSB JET SYRINGE
- K Number
- K834361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- C.B.S. Biotechnics, Inc.
- Date Received
- October 27, 1983
- Decision Date
- March 5, 1984
- 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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