510(k) K864294
- Device
- HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K864294
- Product code
- EGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-04
- Date received
- 1986-10-31
- Regulation
- 872.4475
- Classification name
- Injector, Jet, Mechanical-powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS F WILLER
- Address
- 1820 W. Roscoe St. Chicago IL US 60657 60657
FDA Registration Numbers#
- 9613230
- 2225311
- 3008579121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243427 | QuickSleeper 5 | Dentalhitec | 2025-08-01 |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010-01-14 |
| K964802 | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. | 1997-05-27 |
| K962017 | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. | 1996-07-26 |
| K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | 1990-12-07 |
| K864732 | GRADTECH SYRINGE SYSTEM | Gradtech | 1987-04-15 |
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | 1987-02-13 |
| K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | 1984-03-05 |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | 1982-05-28 |
| K790193 | MIZZY SYRIJET MARK IV | Mizzy, Inc. | 1979-04-23 |
Legacy Summary#
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FDA Review#
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