HYPODERMIC JET INJECTION APPARATUS
FDA 510(k) clearance K962017 · decided 1996-07-26
Clearance details
- K-number
- K962017
- Device name
- HYPODERMIC JET INJECTION APPARATUS
- Applicant
- American Jet Injector Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-23
- Decision date
- 1996-07-26
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- EGM
- Device class
- 2
- Regulation number
- 872.4475
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lansdale, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| GRADTECH SYRINGE SYSTEM (K864732) | Gradtech | 1987-04-15 |
| INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (K864861) | Instrumentations Unltd. | 1987-02-13 |
| JSB JET SYRINGE (K834361) | C.B.S. Biotechnics, Inc. | 1984-03-05 |
| MAYO SCISSOR STRAIGHT 6 3/4 (K821273) | Conphar, Inc. | 1982-05-28 |
| MIZZY SYRIJET MARK IV (K790193) | Mizzy, Inc. | 1979-04-23 |
Recalls involving this device
No recalls on record reference this clearance.